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  1. 510(k) Clearances

October 2022 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2022


DEVICE: Velano Vascular Blood Collection Adapter 
Velano Vascular                   510(k) NO: K201237(Traditional)
ATTN: Tiffini   Wittwer           PHONE NO : 844 8352668 
221 Pine Street #200              SE DECISION MADE: 03-OCT-22
San Francisco CA  94104           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mico One Orthodontic Screw
Ze Fang Technology Co., Ltd.      510(k) NO: K202163(Traditional)
ATTN: Anita  Chen                 PHONE NO : 8860 939 855759 
No.17, Aly. 81, Ln. 2, Sec. 1, ZhoSE DECISION MADE: 07-OCT-22
Taichung  TW 412                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aurolase Therapy, Laser Delivery Device (LDD)
Nanospectra Biosciences, Inc.     510(k) NO: K202953(Traditional)
ATTN: David  Jorden               PHONE NO : 713 8422720 
8285 El Rio Street, #150          SE DECISION MADE: 03-OCT-22
Houston TX  77054                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nova Primary Glucose Analyzer System
Nova Biomedical Corporation       510(k) NO: K203549(Traditional)
ATTN: Rachel  Gilbert             PHONE NO : 781 6473700 1724
200 Prospect Street               SE DECISION MADE: 18-OCT-22
Waltham ME  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AT-Patch ECG Analysis System
ATsens Co., Ltd                   510(k) NO: K203638(Traditional)
ATTN: KeonHoon  Lee               PHONE NO : 82 70 52200220 
Point Town 806, 11, Gumi-ro, BundaSE DECISION MADE: 12-OCT-22
Seongnam-si  KR 13637             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown, Model number: IL-4036YKTP-L4, CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown, Model number: IL-4063WKTP-L4, CoverU Disposable Gown with Tape Chemo Gown, Model number: IL-4036YKTP-CM, CoverU Disposable Gown with Tape Chemo Gown, Model number: IL-4063WKTP-CM
Medtecs (Taiwan) Corp.            510(k) NO: K210414(Traditional)
ATTN: William  Yang               PHONE NO : 886 2 27392222 
11F., No. 9, Songgao Road, Xinyi DSE DECISION MADE: 21-OCT-22
Taipei City  TW 11073             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Gown Rk-3011C
Xiantao Rhycom Non-woven Products 510(k) NO: K211060(Traditional)
ATTN: Liu  Yang                   PHONE NO : 86 152 71157850 
Chuangye Road, Longhuashan Sub-disSE DECISION MADE: 28-OCT-22
Xiantao  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
Guangzhou Sonostar Technologies Co510(k) NO: K211321(Abbreviated)
ATTN: Weizhong  Cai               PHONE NO : 86 20 32382095 
504#, C Building,#27 Yayingshi RoaSE DECISION MADE: 13-OCT-22
Guangzhou  CN 510665              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Proximerge 2 Dental Implant System
Quadric BioMed, LLC               510(k) NO: K211409(Traditional)
ATTN: Aaron  Bass                 PHONE NO : 719 2700755 
640 Southpointe Court #150        SE DECISION MADE: 19-OCT-22
Colorado Springs CO  80906        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CREOKORREKT Aligners
CreoDent Prosthetics LTD          510(k) NO: K211427(Traditional)
ATTN: Calvin  Shim                PHONE NO : 212 3023860 
515 West 45th Street 11FL         SE DECISION MADE: 13-OCT-22
New York NY  10036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CASSATT™ SIJ Fixation System
CTL Medical Corporation           510(k) NO: K211785(Traditional)
ATTN: Sean  Suh                   PHONE NO : 214 5455820 
4550 Excel Parkway                SE DECISION MADE: 17-OCT-22
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PiezoImplant System
Rex Implants, Inc.                510(k) NO: K211872(Traditional)
ATTN: Giuseppe  Vercellotti       PHONE NO : 614 4594922 
850 Michigan Avenue               SE DECISION MADE: 12-OCT-22
Columbus OH  43215                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
ARFTX Medical LLC                 510(k) NO: K211892(Traditional)
ATTN: Ozgen  Ozfidan              PHONE NO : 917 4452085 
50 Laura Street #2524             SE DECISION MADE: 06-OCT-22
Jacksonville FL  32202            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A&D Medical UM-212BLE Blood Pressure Monitor
A&D Company, Ltd                  510(k) NO: K212168(Traditional)
ATTN: Chanda  Melville            PHONE NO : 678 2308565 
1756 Automation Parkway           SE DECISION MADE: 06-OCT-22
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PCA Syringe Sets
Baxter Healthcare Corporation     510(k) NO: K212262(Traditional)
ATTN: Jeffrey E. Thompson         PHONE NO : 224 2703806 
25212 West Illinois Route 120     SE DECISION MADE: 03-OCT-22
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MCI-Neuro Fixation System
MCI Medical Concept Innovation Inc510(k) NO: K212391(Traditional)
ATTN: Carlos  Lacerda             PHONE NO : 01 954 3062521 
4592 North Hiatus Road            SE DECISION MADE: 21-OCT-22
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Welch Allyn Connex Central Station
Welch Allyn, Inc.                 510(k) NO: K212473(Traditional)
ATTN: Megan  Pellenz              PHONE NO : 315 5694257 
4341 State Street Road            SE DECISION MADE: 28-OCT-22
Skaneateles Falls NY  13153       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KODEX – EPD™ System 1.5.0
Philips Medical Systems Nederland,510(k) NO: K212493(Traditional)
ATTN: Betina  Schepers            PHONE NO : 31 611 710116 
Veenpluis 4-6                     SE DECISION MADE: 24-OCT-22
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Face Mask
Lyncmed Medical Technology (Beijin510(k) NO: K212649(Traditional)
ATTN: Naomi  Zhou                 PHONE NO : 86 10 86468058 
Room 1601, Building No. 2, ZhubangSE DECISION MADE: 25-OCT-22
Beijing  CN 100022                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IM/ST Fixture System
Guilin FiTeeth Medical Instrument 510(k) NO: K212702(Traditional)
ATTN: Jun  Zhou                   PHONE NO : 86 773 2350558 
Southeast Side of Renmin Road ExteSE DECISION MADE: 13-OCT-22
Guilin  CN 541199                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORAcollect®•Dx
DNA Genotek Inc                   510(k) NO: K212745(Traditional)
ATTN: Austin  Udocor              PHONE NO : 613 3153476 
3000 - 500 Palladium Drive        SE DECISION MADE: 27-OCT-22
Ottawa  CA K2V 1C2                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATTUNE Revision Cones
Depuy Ireland UC                  510(k) NO: K212746(Traditional)
ATTN: Erin  Combs                 PHONE NO : 574 4048348 
Loughbeg                          SE DECISION MADE: 17-OCT-22
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
CoaguSense, Inc.                  510(k) NO: K212779(Special)
ATTN: Michael  Acosta             PHONE NO : 510 8922379 
48377 Fremont Blvd. Suite 113     SE DECISION MADE: 05-OCT-22
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Varixis Elbow System
Auxein Medical Private Limited    510(k) NO: K213014(Traditional)
ATTN: Rahul  Luthra               PHONE NO : 91 971 7586969 
Plot No.168,169,170 Phase-IV, SectSE DECISION MADE: 03-OCT-22
Sonipat  IN 131028                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STIMPOD NMS450 Nerve Stimulator
Xavant Technology (Pty) Ltd       510(k) NO: K213049(Traditional)
ATTN: Roche Janse van Rensburg    PHONE NO : 27 12 7435959 
Unit 102 Tannery Industrial Park, SE DECISION MADE: 16-OCT-22
Pretoria  ZA 0184                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperCheck Pro Blood Glucose Monitoring System
OK BioTech Co., Ltd.              510(k) NO: K213061(Traditional)
ATTN: Laurie  Liu                 PHONE NO : 886 3 5160258___ 
No. 91, Sec. 2, Gongdao 5th Rd.   SE DECISION MADE: 07-OCT-22
Hsinchu City  TW 30070            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTI Interna Dental Implant System UnicCa - Prosthetic Components
B.T.I. Biotechnology Institute, SL510(k) NO: K213106(Traditional)
ATTN: Jose Ramon Rivero           PHONE NO : 0034 945 297030 
Leonardo Da Vinci 14, Parque TechnSE DECISION MADE: 20-OCT-22
Minano  ES 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OW100S (model OW100S-US)
Tissue Regeneration Technologies, 510(k) NO: K213120(Traditional)
ATTN: John  Warlick               PHONE NO : 
251 Heritage Walk                 SE DECISION MADE: 12-OCT-22
Woodstock GA  30188               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Wrist Spanning Plate
Smith & Nephew, Inc.              510(k) NO: K213123(Traditional)
ATTN: Jyothsna  Baravatula        PHONE NO : 901 4565171 
1450 E Brooks Rd                  SE DECISION MADE: 18-OCT-22
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: System, Image Processing, Radiological
Xironetic, LLC                    510(k) NO: K213128(Traditional)
ATTN: Christian El Amm            PHONE NO : 405 4123574 
712 N Broadway Ave                SE DECISION MADE: 21-OCT-22
Oklahoma City OK  73102           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Insulin Pen Needles
Zhejiang Kindly Medical Devices Co510(k) NO: K213183(Traditional)
ATTN: Yong  Zhang                 PHONE NO : 86 138 06556169 
No.758, 5th Binhai Road, Binhai InSE DECISION MADE: 14-OCT-22
Wenzhou  CN 325025                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPIFE A1AT kit
Helena Laboratories, Corp.        510(k) NO: K213396(Traditional)
ATTN: Rachel  Easley              PHONE NO : 409 8423714 
1530 Lindbergh Drive              SE DECISION MADE: 13-OCT-22
Beaumont TX  77707                510(k) STATEMENT
                                                    

DEVICE: AccuSert Needle Inserter
Emed Technologies Corporation     510(k) NO: K213429(Traditional)
ATTN: Peter  Kollings             PHONE NO : 916 9320071 
1262 Hawks Flight Ct, Ste. 200    SE DECISION MADE: 20-OCT-22
El Dorado Hills CA  95762         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL Liquid Anti-Xa
Instrumentation Laboratory Co.    510(k) NO: K213464(Special)
ATTN: Carol  Marble               PHONE NO : 781 8614467 
180 Hartwell Road                 SE DECISION MADE: 04-OCT-22
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Houdini Cross Support Catheter
Cruzar Medsystems Inc             510(k) NO: K213466(Traditional)
ATTN: Dave  Tornatore             PHONE NO : 412 9656673 
50 Braintree Hill Office Park SuitSE DECISION MADE: 20-OCT-22
Braintree MA  02184               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
Katalyst Surgical, LLC            510(k) NO: K213610(Traditional)
ATTN: Liz  Morgan                 PHONE NO : 636 5365950 
754 Goddard Ave                   SE DECISION MADE: 07-OCT-22
Chesterfield MO  63005            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuCath Wedge Pressure Catheter
PFM Medical, Inc.                 510(k) NO: K213666(Traditional)
ATTN: Jessica  Jho                PHONE NO : 760 7588749 
1916 Palomar Oaks Way Suite 150   SE DECISION MADE: 06-OCT-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse Blood Collection Set
Eclipse Medcorp LLC               510(k) NO: K213690(Traditional)
ATTN: Julie  Summerville          PHONE NO : 972 3802911 
5916 Stone Creek Drive Suite #120 SE DECISION MADE: 26-OCT-22
The Colony TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORiGO System
Bien-Air Surgery SA               510(k) NO: K213697(Traditional)
ATTN: Sveva  Crivelli             PHONE NO : 41 32 3446440 
Rue de l'Ouest 2b                 SE DECISION MADE: 31-OCT-22
Le Noirmont  CH 2340              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinity Pro, Logic, Quality, Sprint
Olsen Indústria e Comércio S.A.   510(k) NO: K213742(Traditional)
ATTN: Ana Cláudia  Espíndola      PHONE NO : 55 48 21066000 
Av. Ivo Luchi, 68                 SE DECISION MADE: 19-OCT-22
Palhoça  BR 88133-510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreLevee
Lutronic Corporation              510(k) NO: K213748(Traditional)
ATTN: Haewon  Park                PHONE NO : 978 4474763 
Lutronic Center, 219, Sowon-Ro    SE DECISION MADE: 14-OCT-22
Deogyang-Gu, Goyang-si  KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
Roche Molecular Systems, Inc.     510(k) NO: K213804(Traditional)
ATTN: Rita  Hoady                 PHONE NO : 925 4871055 
4300 Hacienda Drive               SE DECISION MADE: 22-OCT-22
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ONVOY Acetabular System
Globus Medical Inc.               510(k) NO: K213842(Traditional)
ATTN: Jennifer  Antonacci         PHONE NO : 610 9301800 1861
2560 General Armistead Ave.       SE DECISION MADE: 03-OCT-22
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeartFlow Analysis
HeartFlow, Inc.                   510(k) NO: K213857(Traditional)
ATTN: Windi  Hary                 PHONE NO : 415 5313435 
1400 Seaport Boulevard, Building BSE DECISION MADE: 14-OCT-22
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisionAir Patient-Specific Airway Stent
New COS Inc. DBA VisionAir Solutio510(k) NO: K213969(Traditional)
ATTN: Keith  Grafmeyer            PHONE NO : 440 3134099 
7100 Euclid Ave, Ste 180          SE DECISION MADE: 07-OCT-22
Cleveland OH  44103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TELIGEN System
Medos International, SARL         510(k) NO: K213978(Traditional)
ATTN: Daria  Bochenek             PHONE NO : 41 61 9656154 
Chemin-Blanc 38                   SE DECISION MADE: 18-OCT-22
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
TP Orthodontics, Inc.             510(k) NO: K214054(Traditional)
ATTN: Cristiane  Muller           PHONE NO : 219 7852591 
100 Center Plaza                  SE DECISION MADE: 14-OCT-22
La Porte IN  46350-9672           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eWave Monitor
WearLinq, Inc.                    510(k) NO: K214073(Traditional)
ATTN: Konrad  Morzkowski          PHONE NO : 650 7858742 
1819 Polk St #148                 SE DECISION MADE: 20-OCT-22
San Francisco CA  94109           510(k) STATEMENT
                                                    

DEVICE: PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Kontour(Xi’an) Medical Technology 510(k) NO: K214109(Traditional)
ATTN: Rongrong  Cong              PHONE NO : 086 29 63364685 
No.6, Qinling Avenue, Caotang TechSE DECISION MADE: 28-OCT-22
Xi'an  CN 710304                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AAMI4 Isolation Gown
Hubei Xinxin Non-woven Co.,Ltd.   510(k) NO: K214116(Traditional)
ATTN: Nicole  Jin                 PHONE NO : 86 728 2618155 
Taizihu Industrial Park, PengchangSE DECISION MADE: 11-OCT-22
Xiantao  CN 433018                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
Shinva Ande Healthcare Apparatus C510(k) NO: K220057(Traditional)
ATTN: Xiaolei  Tian               PHONE NO : 86 0533 3917821 
No.77 Development Zone North Road,SE DECISION MADE: 07-OCT-22
Zibo  CN 255086                   510(k) STATEMENT
                                                    

DEVICE: YADU Surgical Gowns
HeNan YADU Industrial Co., Ltd.   510(k) NO: K220092(Traditional)
ATTN: Charles  Shen               PHONE NO : 1 608 2179358 
No. 234, West Jianpu Road         SE DECISION MADE: 07-OCT-22
Changyuan  CN 453400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eClinic Stethopod
HomeDiagnostic LLC                510(k) NO: K220099(Third Party - Traditional)
ATTN: Jian  Gong                  PHONE NO : 1 866 9764038 
3160 De La Cruz Blvd Suite 100    SE DECISION MADE: 20-OCT-22
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MOST-T Autoclave
Shinva Medical Instrument Co., Ltd510(k) NO: K220102(Traditional)
ATTN: Liu  Xiaolin                PHONE NO : 86 0533 3587752 
Xinhua Medical Scientific Zone, ZiSE DECISION MADE: 12-OCT-22
Zibo  CN 255086                   510(k) STATEMENT
                                                    

DEVICE: RespiraSense
PMD Solutions                     510(k) NO: K220111(Traditional)
ATTN: Sinead  O'Sullivan          PHONE NO : 353 0 212428760 
Bishopstown House Model Farm Rd   SE DECISION MADE: 07-OCT-22
Cork  IE T12 T922                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIREFLY® Cervical Navigation Guide
Mighty Oak Medical Inc.           510(k) NO: K220132(Traditional)
ATTN: Mark A. Wylie               PHONE NO : 720 3989703 
750 W. Hampden Avenue, Suite 120  SE DECISION MADE: 26-OCT-22
Englewood CO  80110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
LED SpA                           510(k) NO: K220138(Traditional)
ATTN: Amalia  Lamberti            PHONE NO : 39 06 92870045 
Via Selciatella, 40               SE DECISION MADE: 05-OCT-22
Aprilia  IT 04011                 510(k) STATEMENT
                                                    

DEVICE: ClearCorrect System
ClearCorrect, LLC                 510(k) NO: K220140(Traditional)
ATTN: Christopher  Klaczyk        PHONE NO : 512 8315128 
21 Cypress Boulevard, Suite 1010  SE DECISION MADE: 05-OCT-22
Round Rock TX  78665              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrically Powered Wheelchair, Joy Rider
Tung Keng Enterprise Co., Ltd.    510(k) NO: K220156(Traditional)
ATTN: Jen  Ke-Min                 PHONE NO : 886 4 25351000 
No. 1, Lane 160, Sec. 2, Tan-Fu RoSE DECISION MADE: 07-OCT-22
Taichung City  CN                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enteral Transition Adaptor
GBUK Group Ltd                    510(k) NO: K220165(Traditional)
ATTN: Rachael  Hume               PHONE NO : 44 0 1757606992 
Blackwood Hall Business Park, NortSE DECISION MADE: 21-OCT-22
Selby  GB YO85DD                  510(k) STATEMENT
                                                    

DEVICE: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)
Bionet Co., Ltd.                  510(k) NO: K220169(Traditional)
ATTN: ChuelWon  Lee               PHONE NO : 82 102 0672442 
5F, 61 Digital-ro 31-gil Guro-gu  SE DECISION MADE: 11-OCT-22
Seoul  KR 08375                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The GIRO Growth Modulation System
Pega Medical, Inc.                510(k) NO: K220190(Traditional)
ATTN: Ariel R. Dujovne            PHONE NO : 450 6885144 241
1111 Autoroute Chomedey           SE DECISION MADE: 24-OCT-22
Laval  CA H7W 5J8                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Sphygmomanometer (Model: LT-P30)
Zhuhai Linte Medical Instrument Co510(k) NO: K220220(Traditional)
ATTN: Wallace  Huang              PHONE NO : 86 1382 3146691 
4th Floor, Building 1, No.66, YongSE DECISION MADE: 03-OCT-22
Zhuhai  CN 519090                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Auto Folding Scooter, S21F
Heartway Medical Products Co., Ltd510(k) NO: K220227(Traditional)
ATTN: Ke-Min  Jen                 PHONE NO : 886 4 23583232 
No.18, Jingke Central 1st Rd., NanSE DECISION MADE: 12-OCT-22
Taichung City  TW 40852           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIM-Ablation
MIM Software Inc.                 510(k) NO: K220256(Traditional)
ATTN: Daniel  Darkow              PHONE NO : 216 4550600 
25800 Science Park Drive - Suite 1SE DECISION MADE: 07-OCT-22
Cleveland OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSafe NeuFlo Needleless Connector
Amsino International, Inc.        510(k) NO: K220267(Traditional)
ATTN: Jane  Gao                   PHONE NO : 86 139 16147664 
708 Corporate Center Drive        SE DECISION MADE: 07-OCT-22
Pomona CA  91768                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Onetouch Non-paraben Lubricant Gel
Thai Nippon Rubber Industry Public510(k) NO: K220273(Traditional)
ATTN: Tossaporn  Nilkhamhang      PHONE NO : 66 38 317999 
789/139 Pinthong Industrial EstateSE DECISION MADE: 21-OCT-22
Sriracha  TH 20230                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
Syntheon                          510(k) NO: K220305(Traditional)
ATTN: Sean  McBryer               PHONE NO : 305 2663388 
13755 SW 119 Avenue               SE DECISION MADE: 28-OCT-22
Miami FL  33186                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PAL Infiltration System
MicroAire Surgical Instruments, LL510(k) NO: K220318(Traditional)
ATTN: Glenn  Gerstenfeld          PHONE NO : 434 9758013 
3590 Grand Forks Blvd             SE DECISION MADE: 14-OCT-22
Charlottesville VA  22911         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare510(k) NO: K220332(Traditional)
ATTN: Xin  Gao                    PHONE NO : 
NO.2258 Chengbei Road, Jiading DisSE DECISION MADE: 27-OCT-22
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gemini Sterilization Wrap
Medline Industries, LP            510(k) NO: K220365(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
Three Lakes Drive                 SE DECISION MADE: 06-OCT-22
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PADnet Xpress
Collaborative Care Diagnostics LLC510(k) NO: K220527(Special)
ATTN: James  Hartnett             PHONE NO : 651 2805570 
860 Blue Gentian Rd Suite 180     SE DECISION MADE: 20-OCT-22
Eagan MN  55121                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Colibrí System
Copan WASP S.r.l.                 510(k) NO: K220546(Traditional)
ATTN: Giovanna  Catalano          PHONE NO : 39 331 6746551 
Via A. Grandi, 32                 SE DECISION MADE: 05-OCT-22
Brescia  IT 25125                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hudson RCI Triflo II Incentive Deep Breathing Exerciser
Medline Industries, Inc.          510(k) NO: K220565(Traditional)
ATTN: Nicole  Schaffer            PHONE NO : 724 6409680 
1 Three Lakes Drive               SE DECISION MADE: 25-OCT-22
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
Penumbra, Inc.                    510(k) NO: K220683(Traditional)
ATTN: Sindokht (Sisi)  SoltanzadehPHONE NO : 269 3309520 
One Penumbra Place                SE DECISION MADE: 04-OCT-22
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BriefCase
Aidoc Medical, Ltd.               510(k) NO: K220709(Traditional)
ATTN: Nimrod  Epstein             PHONE NO : 972 73 7946870 
3 Aminadav St.,                   SE DECISION MADE: 07-OCT-22
Tel Aviv  IL 6706703              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: allFlex Ureteral Catheters, Krait Ureteral Catheters
Allwin Medical Devices, Inc       510(k) NO: K220730(Traditional)
ATTN: Digish  Mehta               PHONE NO : 714 5721709 
3305 E. Miraloma Avenue, Suite 176SE DECISION MADE: 13-OCT-22
Anaheim CA  92806                 510(k) STATEMENT
                                                    

DEVICE: VITEK 2 AST-Gram Positive Cefoxitin Screen
bioMerieux, Inc                   510(k) NO: K220805(Traditional)
ATTN: Debra  Broyles              PHONE NO : 314 7318805 
595 Anglum Rd.                    SE DECISION MADE: 13-OCT-22
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Preat Abutments
Preat Corporation                 510(k) NO: K220823(Traditional)
ATTN: Chris  Bormes               PHONE NO : 1 800 2327732 
2625 Skyway Dr, Suite B           SE DECISION MADE: 26-OCT-22
Santa Maria CA  93455             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iCare IC200
Icare Finland Oy                  510(k) NO: K220852(Traditional)
ATTN: Hannes  Hyvönen             PHONE NO : 358 9 87751150 
Ayritie 22                        SE DECISION MADE: 06-OCT-22
Vantaa  FI 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoWay Laser System
Candela Corporation               510(k) NO: K220853(Traditional)
ATTN: Danielle  Gibboney          PHONE NO : 617 9043820 
251 Locke Drive                   SE DECISION MADE: 13-OCT-22
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-CUBE 50, X-CUBE 60
Alpinion Medical Systems Co., Ltd.510(k) NO: K220857(Traditional)
ATTN: Boyeon  Cho                 PHONE NO : 82 70 74652104 
5FL, I dong, 77, heungan-daero 81bSE DECISION MADE: 13-OCT-22
Anyang-si  KR 14117               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vapotherm Aerosol Adapter AAA-2
Vapotherm Inc.                    510(k) NO: K220869(Traditional)
ATTN: Michael J. Webb             PHONE NO : 978 3147212 
100 Domain Drive                  SE DECISION MADE: 28-OCT-22
Exeter NH  03833                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
BioFire Defense, LLC              510(k) NO: K220870(Traditional)
ATTN: Cynthia  Pillips            PHONE NO : 801 2623592 1370
79 W 4500 S, Suite 14             SE DECISION MADE: 20-OCT-22
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex BioSuture
Arthrex Inc.                      510(k) NO: K220880(Special)
ATTN: Stacy  Valdez               PHONE NO : 1 239 6435553 72010
1370 Creekside Boulevard          SE DECISION MADE: 27-OCT-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IO Needle Safety Sheath
Actuated Medical, Inc             510(k) NO: K220890(Traditional)
ATTN: Douglas R. Dillon           PHONE NO : 814 3550003 
310 Rolling Ridge Drive           SE DECISION MADE: 31-OCT-22
Bellefonte PA  16823              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys CMV IgG
Roche Diagnostics                 510(k) NO: K220911(Traditional)
ATTN: Bin  Sun                    PHONE NO : 317 2923781 
9115 Hague Road                   SE DECISION MADE: 12-OCT-22
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tornier Perform Humeral System – Fracture
Tornier, Inc.                     510(k) NO: K220914(Traditional)
ATTN: Renee  Stoffel              PHONE NO : 952 6837471 
10801 Nesbitt Ave South           SE DECISION MADE: 14-OCT-22
Bloomington MN  55437             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys HSV-1 IgG (08948844160)
Roche Diagnostics                 510(k) NO: K220923(Traditional)
ATTN: Cynthia  Aker               PHONE NO : 1 463 3362138 
9115 Hague Road PO Box 50416      SE DECISION MADE: 12-OCT-22
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys HSV-2 IgG (08948887160)
Roche Diagnostics                 510(k) NO: K220924(Traditional)
ATTN: Cynthia  Aker               PHONE NO : 1 463 3362138 
9115 Hague Road PO Box 50416      SE DECISION MADE: 12-OCT-22
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Excelsior
Merit CRO, Inc.                   510(k) NO: K220929(Traditional)
ATTN: Yijuan  Huang               PHONE NO : 608 8863386 
6527 Normandy Lane, Suite 100     SE DECISION MADE: 31-OCT-22
Madison WI  53719                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Architect CMV IgG
Abbott Laboratories               510(k) NO: K220949(Traditional)
ATTN: Shannon  Reibling           PHONE NO : 224 6683735 
Dept 09AA, Bldg. AP8A, 100 Abbott SE DECISION MADE: 27-OCT-22
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
Ever Global (Vietnam) Enterprise C510(k) NO: K220992(Traditional)
ATTN: Jerry  Lin                  PHONE NO : 84 61 3514022 
Long Thanh Industrial Zone, Taman SE DECISION MADE: 19-OCT-22
Long Thanh  VN 810000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shoulder PacemakerTM
NCS Lab Srl                       510(k) NO: K220994(Traditional)
ATTN: Matteo  Mantovani           PHONE NO : 39 059 669813 
Via Pola Esterna 4/12             SE DECISION MADE: 14-OCT-22
Carpi MO  41012                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
Effortless Oxygen. LLC            510(k) NO: K221014(Traditional)
ATTN: Samir  Ahmad                PHONE NO : 
251 E Sierra Dr.                  SE DECISION MADE: 17-OCT-22
Phoenix AZ  85012                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NextDent Ortho Flex
Vertex-Dental BV                  510(k) NO: K221022(Abbreviated)
ATTN: Connie  Peterse-van der KoppPHONE NO : 31 88 6160412 
Centurionbaan 190                 SE DECISION MADE: 21-OCT-22
Soesterberg  NL 3769AV            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
Synovis Life Technologies, Inc.   510(k) NO: K221029(Traditional)
ATTN: Megan  Sajjad               PHONE NO : 414 2181464 
(A Subsidiary of Baxter InternatioSE DECISION MADE: 19-OCT-22
St. Paul MN  55114                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vascu-Guard Vascular Repair Patch
Synovis Life Technologies, Inc.   510(k) NO: K221032(Traditional)
ATTN: Sajjad  Megan               PHONE NO : 414 2181464 
(A Subsidiary of Baxter InternatioSE DECISION MADE: 19-OCT-22
St. Paul MN  55114                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SILO TFX MIS Sacroiliac Joint Fixation System
Aurora Spine, Inc.                510(k) NO: K221047(Traditional)
ATTN: Laszlo  Garamszegi          PHONE NO : 760 4242004 
1930 Palomar Point Way, Suite #103SE DECISION MADE: 03-OCT-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nuheara IQbuds 2 PRO Hearing Aid
Nuheara Limited                   510(k) NO: K221064(Traditional)
ATTN: John  Luna                  PHONE NO : 425 2091646 
13555 S.E. 36th St.,  Suite 100   SE DECISION MADE: 30-OCT-22
Bellevue WA  98006                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Needles for Single Use
Sichuan Prius Biotechnology Co., L510(k) NO: K221066(Traditional)
ATTN: Yan  Liu                    PHONE NO : 86 831 3839889 
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin  CN 644104                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Syringes for Single Use with Needles
Sichuan Prius Biotechnology Co., L510(k) NO: K221068(Traditional)
ATTN: Yan  Liu                    PHONE NO : 86 831 3839889 
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin  CN 644104                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRUEdraw Lancing Device, Mini Lancing Device
Trividia Health                   510(k) NO: K221072(Traditional)
ATTN: Jacqueline  Davis           PHONE NO : 800 3427226 
2400 N.W. 55th Court              SE DECISION MADE: 18-OCT-22
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Syringes for Single Use with Safety Needles
Sichuan Prius Biotechnology Co., L510(k) NO: K221073(Traditional)
ATTN: Yan  Liu                    PHONE NO : 86 831 3839889 
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin  CN 644104                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Syringes for Single Use
Sichuan Prius Biotechnology Co., L510(k) NO: K221079(Traditional)
ATTN: Yan  Liu                    PHONE NO : 86 831 3839889 
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin  CN 644104                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Safety Hypodermic Needles for Single Use
Sichuan Prius Biotechnology Co., L510(k) NO: K221080(Traditional)
ATTN: Yan  Liu                    PHONE NO : 86 831 3839889 
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 04-OCT-22
Yibin  CN 644104                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-CUBE 70, X-CUBE 90
Alpinion Medical Systems Co., Ltd.510(k) NO: K221093(Traditional)
ATTN: Boyeon  Cho                 PHONE NO : 82 70 74652104 
5FL, I dong, 77, heungan-daero 81bSE DECISION MADE: 14-OCT-22
Anyang-si  KR 14117               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
Arthrex Inc.                      510(k) NO: K221128(Traditional)
ATTN: Lai  Saeteurn               PHONE NO : 1 239 5984302 71764
1370 Creekside Boulevard          SE DECISION MADE: 05-OCT-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infant Heel WarmerTM; Heel Snuggler®
International Biomedical          510(k) NO: K221154(Traditional)
ATTN: Amy  Pieper                 PHONE NO : 512 8730033 
8206 Cross Park Drive             SE DECISION MADE: 07-OCT-22
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JR MEDIC Nitrile Examination Gloves Powder Free- Black
JR Engineering & Medical Technolog510(k) NO: K221169(Abbreviated)
ATTN: Ganesan  Subramaniam        PHONE NO : 603 605 72081 
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 25-OCT-22
Hulu Selangor  MY 44200           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
Shenzhen AOJ Medical Technology Co510(k) NO: K221170(Traditional)
ATTN: Jack  Wang                  PHONE NO : 86 755 27786026 
Room 301&4F, Blk A, Building A, JiSE DECISION MADE: 07-OCT-22
Shenzhen  CN 518126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FOCUS Interbody System
OC Medical Devices                510(k) NO: K221172(Traditional)
ATTN: Jack  Mathews               PHONE NO : 888 4635803 
15 East Montgomery Crossroads, SuiSE DECISION MADE: 14-OCT-22
Savannah GA  31406                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-Lancet Device 2, ReliOn Premier Lancing Device
Arkray, Inc.                      510(k) NO: K221175(Traditional)
ATTN: Shinjiro  Sekimoto          PHONE NO : 81 50 58300922 
Yousuien-nai, 59 Gansuin-cho, KamiSE DECISION MADE: 17-OCT-22
Kyoto  JP 602-0008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silverlon Wound Contact, Burn Contact Dressings
Argentum Medical, Inc.            510(k) NO: K221218(Traditional)
ATTN: Kathy  Herzog               PHONE NO : 612 7994562 
2571 Kaneville Ct                 SE DECISION MADE: 26-OCT-22
Geneva IL  60134                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aqua Naina Plus Sterile Saline Solution
Chemtex USA Inc.                  510(k) NO: K221263(Special)
ATTN: Haribabu  Talasila          PHONE NO : 732 4474353 
27-29 Dwight Place                SE DECISION MADE: 12-OCT-22
Fairfield NJ  07004-3303          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc510(k) NO: K221305(Traditional)
ATTN: Kira  Kuzmenchuk            PHONE NO : 1 484 9019471 
40 Liberty Blvd. Mail Code 65-3   SE DECISION MADE: 14-OCT-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Jiangxi Maidikang Medical Devices 510(k) NO: K221308(Traditional)
ATTN: Wu  Huansheng               PHONE NO : 86 136 17915949 
Room 308, floor 3, building 1, JiaSE DECISION MADE: 17-OCT-22
Yichun  CN                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
Changzhou Endoclean Medical Device510(k) NO: K221310(Traditional)
ATTN: Wang  Qi                    PHONE NO : 86 0519 68213060 
West Side of 4th Floor, Building ESE DECISION MADE: 07-OCT-22
Changzhou  CN 213149              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
GE Medical Systems Information Tec510(k) NO: K221321(Traditional)
ATTN: Honghong  Yang              PHONE NO : 86 1391 5289019 
9900 Innovation Drive             SE DECISION MADE: 18-OCT-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUSTMBITE Snoring System
Dental Choice Holdings LLC        510(k) NO: K221322(Traditional)
ATTN: Danielle M Jackson          PHONE NO : 502 7364647 
10100 Linn Station Road           SE DECISION MADE: 27-OCT-22
Louisville KY  40223              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YUWELL Electronic Blood Pressure Monitor
Jiangsu Yuyue Medical Equipment & 510(k) NO: K221372(Traditional)
ATTN: Yinzhen  Zhu                PHONE NO : 86 188131 85546 
No.1 Baisheng Road Development ZonSE DECISION MADE: 17-OCT-22
Danyang  CN 212300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
Hebei Titans Hongsen Medical Techn510(k) NO: K221374(Traditional)
ATTN: Chai  Wu                    PHONE NO : 86 177 69045117 
Eastern Industrial Zone, Nangong CSE DECISION MADE: 26-OCT-22
Xingtai  CN 051800                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vented Vial Transfer Pin
Jiangsu Caina Medical Co., Ltd.   510(k) NO: K221406(Traditional)
ATTN: Jianwei  Pan                PHONE NO : 86 510 86205183 
No.23, Huanxi Road, Zhutang Town  SE DECISION MADE: 28-OCT-22
Jiangyin  CN 214415               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlphaID™ At Home Genetic Health Risk Service
Progenika Biopharma S.A., a Grifol510(k) NO: K221420(Traditional)
ATTN: Diego  Tejedor              PHONE NO : 34 944 064525 
Ibaizabal bidea, Edificio 504, ParSE DECISION MADE: 27-OCT-22
Derio  ES 48160                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUPERTILT PLUS (STP)
Power Plus Mobility               510(k) NO: K221435(Traditional)
ATTN: Jason  Mohan                PHONE NO : 416 8091301 
50 Malcom Rd                      SE DECISION MADE: 28-OCT-22
Guelph  CA N1K1A9                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PureLift Pro Plus
Xtreem Pulse LLC                  510(k) NO: K221443(Special)
ATTN: Andrew  Barile              PHONE NO : 212 6439062 
353 W. 29 St. Suite 3             SE DECISION MADE: 21-OCT-22
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Southern Anterior Screw Fixated Cage (SASCA)
Southern Medical (Pty) Ltd        510(k) NO: K221447(Traditional)
ATTN: Dalene  Styger              PHONE NO : 27 12 66762434 
55 Regency Drive, Route 21 CorporaSE DECISION MADE: 14-OCT-22
Irene  ZA 0178                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genius AI Detection 2.0
Hologic, Inc.                     510(k) NO: K221449(Traditional)
ATTN: Deborah  Thomas             PHONE NO : 508 2106107 
250 Campus Drive                  SE DECISION MADE: 06-OCT-22
Marlborough MA  01730             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Reclaim Monobloc Revision Femoral Stem
DePuy Ireland UC                  510(k) NO: K221462(Traditional)
ATTN: Jennifer  Hill              PHONE NO : 44 783 4974433 
                                  SE DECISION MADE: 21-OCT-22
Loughbeg  IE P43 ED82             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Artemis Proximal Femoral Nail System
GLW, Inc.                         510(k) NO: K221489(Traditional)
ATTN: Arundhati  Radhakrishnan    PHONE NO : 201 2683281 
300 Sylvan Avenue                 SE DECISION MADE: 27-OCT-22
Englewood Cliffs NJ  07632        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SteriTite Container System with MediTray Parts
Case Medical, Inc.                510(k) NO: K221492(Traditional)
ATTN: Michael  Polozani           PHONE NO : 201 3131999 633
50 West Street                    SE DECISION MADE: 07-OCT-22
Bloomfield NJ  07003              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Miha Bodytec II
Miha Bodytec GmbH                 510(k) NO: K221498(Traditional)
ATTN: Felix  Schweigert           PHONE NO : 49 821 45549222 
Siemensstr. 1                     SE DECISION MADE: 07-OCT-22
Gersthofen  DE 86368              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.via View&GO
Siemens Healthcare GmBH           510(k) NO: K221501(Traditional)
ATTN: Frederike  Jakob            PHONE NO : 49 0162 1092694 
Siemensstraße 1, Forchheim        SE DECISION MADE: 14-OCT-22
Erlangen  DE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Surgiphor™ Antimicrobial Irrigation System
BD                                510(k) NO: K221504(Traditional)
ATTN: Shelley  Wilcox             PHONE NO : 720 2766575 
75 N Fairway Dr                   SE DECISION MADE: 14-OCT-22
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrusFIL-Flow Flowable Composite Restorative
Rizhao HuGe Biomaterials Company, 510(k) NO: K221510(Traditional)
ATTN: Maggie  Zheng               PHONE NO : 86 633 2277268 
No.2 North Zhaoyang Road, DistrictSE DECISION MADE: 12-OCT-22
Rizhao City  CN 276800            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
Interojo Inc.                     510(k) NO: K221517(Traditional)
ATTN: Si-Chul  Rho                PHONE NO : 82 2 7801225 
28& 25 Sandan-Ro 15 Beon-Gil      SE DECISION MADE: 04-OCT-22
Pyongtaek-City  KR 459040         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Safety Lancet
SteriLance Medical (Suzhou) Inc.  510(k) NO: K221521(Traditional)
ATTN: Susan  Sun                  PHONE NO : 86 1341 8660174 
No.168 PuTuoShan Road, New DistricSE DECISION MADE: 28-OCT-22
Suzhou  CN 215153                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLIF Anterior Extension
Medacta International S.A.        510(k) NO: K221545(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 24-OCT-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neurosteer EEG Recorder
Neurosteer Inc.                   510(k) NO: K221563(Traditional)
ATTN: Nathan  Intrator            PHONE NO : 844 4445601 
375 South End Avenue Suite 26C    SE DECISION MADE: 24-OCT-22
New York NY  10280                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUDWIG Electrosurgical Device
Aesthetics Biomedical             510(k) NO: K221574(Traditional)
ATTN: Lawrence A. Rheins          PHONE NO : 760 8775385 
4602 North 16th Street, Suite 300 SE DECISION MADE: 16-OCT-22
Phoenix AZ  85016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pre-Formed Blue
Lake Region Medical               510(k) NO: K221575(Traditional)
ATTN: Deko  Hussein               PHONE NO : 952 6428302 
340 Lake Hazeltine Drive          SE DECISION MADE: 07-OCT-22
Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ameda Pearl Electric Breast Pump
Ameda, Inc.                       510(k) NO: K221576(Traditional)
ATTN: Sean  Pettibone             PHONE NO : 847 5302552 
485 Half Day Road; Suite 320      SE DECISION MADE: 12-OCT-22
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
Owen Mumford Ltd                  510(k) NO: K221613(Traditional)
ATTN: Darren  Mansell             PHONE NO : 01993 812021 
Owen Mumford, Brook Hill, WoodstocSE DECISION MADE: 03-OCT-22
Woodstock  GB OX20 ITU            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine CAMP™
Medical Metrics, Inc.             510(k) NO: K221632(Traditional)
ATTN: Kirk  Johnson               PHONE NO : 1 210 2188405 
2121 Sage Road                    SE DECISION MADE: 18-OCT-22
Houston TX  77056                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hair Removal Device (Model: IPL-D26, IPL-D19)
Shenzhen Desida Technology Co., Lt510(k) NO: K221643(Traditional)
ATTN: Gong  Yong                  PHONE NO : 86 755 28227189 
5F, Building A, Sanmin Industrial SE DECISION MADE: 21-OCT-22
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K221646(Traditional)
ATTN: Shana  Foster               PHONE NO : 
1800 Pyramid Place                SE DECISION MADE: 04-OCT-22
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InfaTherm Disposable Infant Warming Mattress
International Biomedical          510(k) NO: K221653(Traditional)
ATTN: Amy  Pieper                 PHONE NO : 512 8730033 
8206 Cross Park Drive             SE DECISION MADE: 06-OCT-22
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non Sterile Powder Free Latex Examination Glove
New Era Medicare Sdn. Bhd.        510(k) NO: K221667(Traditional)
ATTN: Fatin Nor Irdina binti AhmadPHONE NO : 60 14 9072860 
Plot 2621-2624                    SE DECISION MADE: 28-OCT-22
Teluk Intan  MY 36000             510(k) STATEMENT
                                                    

DEVICE: Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
Fotona d.o.o.                     510(k) NO: K221712(Traditional)
ATTN: Marko  Berdajs              PHONE NO : 386 1 5009119 
Stegne 7                          SE DECISION MADE: 12-OCT-22
Ljubljana  SI 1000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate
Stryker Corporation               510(k) NO: K221728(Traditional)
ATTN: Katie  McNeil               PHONE NO : 201 7498518 
2 Pearl Court                     SE DECISION MADE: 19-OCT-22
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
Smith and Nephew, Inc.            510(k) NO: K221740(Traditional)
ATTN: Renesha  Srivastava         PHONE NO : 
150 Minuteman Road                SE DECISION MADE: 20-OCT-22
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Cohere ALIF System Intervertebral Body Fusion Device
NuVasive, Incorporated            510(k) NO: K221751(Traditional)
ATTN: Jessica  LeBlanc            PHONE NO : 951 8160973 
7475 Lusk Boulevard               SE DECISION MADE: 21-OCT-22
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cornisol
Aurolab                           510(k) NO: K221759(Traditional)
ATTN: Krishna  Kumar              PHONE NO : 
No.1, Sivagangai Main Road        SE DECISION MADE: 05-OCT-22
Veerapanjan, Madurai  IN 625020   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InBody Blood pressure monitor, Model BPBIO480KV
InBody Co, Ltd.                   510(k) NO: K221764(Traditional)
ATTN: Kichul  Cha                 PHONE NO : 82 02 5013939 
15, Heugam-Gil , Ipjang-Myueon, SeSE DECISION MADE: 07-OCT-22
Cheonan-Si  KR 31025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fiber Laser Treatment System
Shanghai Apolo Medical Technology 510(k) NO: K221770(Traditional)
ATTN: Felix  Li                   PHONE NO : 86 138 49190618 
                                  SE DECISION MADE: 13-OCT-22
Shanghai  CN 200231               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Safety Lancets
Suzhou Kyuan Medical Apparatus Co.510(k) NO: K221778(Traditional)
ATTN: Shi  Ye                     PHONE NO : 86 512 65995113 
Beiqiao Town, Suzhou City, P.R.ChiSE DECISION MADE: 03-OCT-22
Suzhou  CN                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafetiCET (SC-150);SafetiCET (SC-180);SafetiCET (SC-220);SafetiCET (SC-250);SafetiCET (SC-250B)
NSP Tech Pte Ltd                  510(k) NO: K221783(Traditional)
ATTN: HC  Tan                     PHONE NO : 65 981 80450 
10 Admiralty Street,  Northlink BuSE DECISION MADE: 24-OCT-22
Singapore  SG 757695              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERN FIX Sternal Stabilization System
Neos Surgery SL                   510(k) NO: K221795(Traditional)
ATTN: Eduard Garcia Puig          PHONE NO : 
Parc Technologic del Valles       SE DECISION MADE: 19-OCT-22
Barcelona  ES 08290               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
Bonraybio Co., LTD.               510(k) NO: K221810(Traditional)
ATTN: Clare  Huang                PHONE NO : 886 4 24912385 
4F., No. 118, Gongye 9th Rd., DaliSE DECISION MADE: 31-OCT-22
Taichung City  TW 41280           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rebellion; Phantom Multi-Bite Kerrison Rongeur
Morpheus AG                       510(k) NO: K221818(Special)
ATTN: Timo  Rack                  PHONE NO : 49 746 1703820 
Bahnhofstraße 18                  SE DECISION MADE: 07-OCT-22
Spaichingen  DE 78549             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apyx One Console
Apyx Medical Corporation          510(k) NO: K221830(Traditional)
ATTN: David  Ceretti              PHONE NO : 1 727 8038508 
5115 Ulmerton Road                SE DECISION MADE: 11-OCT-22
Clearwater FL  33760-4004         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
Integra LifeSciences Production Co510(k) NO: K221840(Traditional)
ATTN: Amanda  Erwin               PHONE NO : 609 62979053 
11 Cabot Boulevard                SE DECISION MADE: 14-OCT-22
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
Zhejiang LuDe Technology Developme510(k) NO: K221857(Traditional)
ATTN: Iris  Du                    PHONE NO : 86 513 80580127__ 
NO. 298 Jichang North Road, LongwaSE DECISION MADE: 13-OCT-22
Wenzhou  CN 325024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZSFab Lumbar Interbody System
ZS Fab Inc.                       510(k) NO: K221858(Traditional)
ATTN: Xuewei  Ma                  PHONE NO : 617 4688665 
96 Clematis Ave Suite 2F          SE DECISION MADE: 14-OCT-22
Waltham MA  02453                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
23andMe, Inc.                     510(k) NO: K221885(Traditional)
ATTN: Marianna  Frendo            PHONE NO : 650 6869288 
349 Oyster Point Blvd             SE DECISION MADE: 26-OCT-22
South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sublime Microcatheter
Surmodics Inc.                    510(k) NO: K221886(Traditional)
ATTN: Holly  Ramirez              PHONE NO : 952 5007545 
7905 Golden Triangle Drive Suite 1SE DECISION MADE: 14-OCT-22
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
ProSomnus Sleep Technologies      510(k) NO: K221889(Abbreviated)
ATTN: Divya  Mavalli              PHONE NO : 925 3077069 
5860 W Las Positas Blvd. Suite 25 SE DECISION MADE: 06-OCT-22
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VISIONAIR
PacificMD Biotech Llc             510(k) NO: K221892(Traditional)
ATTN: Jetmir  Palushi             PHONE NO : 201 8198685 
3195 Saint Rose Pkwy, Suite 210   SE DECISION MADE: 05-OCT-22
Henderson NV  89052               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Blood Pressure Monitor
Alicn Medical Shenzhen,Inc        510(k) NO: K221913(Special)
ATTN: Fang  Meisong               PHONE NO : 86 755 26501548 
Room 410, Building A, 3rd Sub-parkSE DECISION MADE: 12-OCT-22
Shenzhen  CN 518118               510(k) STATEMENT
                                                    

DEVICE: ROSA® Knee System
Orthosoft d/b/a Zimmer CAS        510(k) NO: K221928(Traditional)
ATTN: Kavina  Veeren              PHONE NO : 514 2458906 
75 Queen Street, Suite 3300       SE DECISION MADE: 04-OCT-22
Montreal  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Standalone ALIF Interbody Fusion System
Eminent Spine                     510(k) NO: K221936(Traditional)
ATTN: Stephen  Courtney           PHONE NO : 214 4155243 
2004 Ventura Drive Suite 100      SE DECISION MADE: 17-OCT-22
Plano TX  75093                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical Staple Fixation System (various)
Tyber Medical, LLC.               510(k) NO: K221947(Traditional)
ATTN: Lisa  Boyle                 PHONE NO : 610 2957984 
83 South Commerce Way Suite 310   SE DECISION MADE: 20-OCT-22
Bethlehem PA  18017               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Branchor Balloon Guide Catheter
Asahi Intecc Co., Ltd             510(k) NO: K221951(Special)
ATTN: Katsuhiko  Fujimura         PHONE NO : 81 561 561859 
3-100 Akatsuki-cho                SE DECISION MADE: 11-OCT-22
Seto  JP 489-0071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flex-MI
EMSI, Inc.                        510(k) NO: K221958(Traditional)
ATTN: Chad  Sagnip                PHONE NO : 813 4710129 
3504 Cragmont Sr., Suite 100      SE DECISION MADE: 21-OCT-22
Tampa FL  33619                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Gown (G4003)
Xiantao Topmed Nonwoven Protective510(k) NO: K221977(Traditional)
ATTN: Vivian  Zhu                 PHONE NO : 86 2787 861070 
North of the National Road 318, ToSE DECISION MADE: 20-OCT-22
Xiantao  CN 433000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter (Model C101A2, C101B1, C101A3)
Shenzhen IMDK Medical Technology C510(k) NO: K221979(Special)
ATTN: Yuan  Xia                   PHONE NO : 86 755 27155684 
C Zone 10F, Building 16, Yuanshan SE DECISION MADE: 16-OCT-22
Shenzhen  CN 518106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Transit Scientific, LLC           510(k) NO: K221986(Special)
ATTN: Jennifer  Arnold            PHONE NO : 412 4963609 
2757 South 300 West, Suite E      SE DECISION MADE: 18-OCT-22
Salt Lake City UT  84115          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Oligio
WON TECH Co., Ltd.                510(k) NO: K221989(Traditional)
ATTN: Hyun Sik Yoon               PHONE NO : 82 10 67505346 
64 Techno 8-ro                    SE DECISION MADE: 13-OCT-22
Yuseong-gu  KR 34028              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Pulse Stimulator
Beijing Choice Electronic Technolo510(k) NO: K221992(Traditional)
ATTN: Haiying  Zhao               PHONE NO : 86 10 88794631 
No.9 Shuangyuan road, Badachu Hi-tSE DECISION MADE: 21-OCT-22
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hailie Sensor NF0107 & NF0108
Adherium (NZ) Ltd                 510(k) NO: K221994(Traditional)
ATTN: Tara  Creaven-Capasso       PHONE NO : 64 9 3072771 
Level 11, 16 Kingston Street      SE DECISION MADE: 04-OCT-22
Auckland  NZ 1010                 510(k) STATEMENT
                                                    

DEVICE: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System
Alphatec Spine                    510(k) NO: K222028(Traditional)
ATTN: Neha  Mohindroo             PHONE NO : 760 3566596 
1950 Camino Vide Roble            SE DECISION MADE: 07-OCT-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spinal Inner Fixation System
Changzhou Geasure Medical Apparatu510(k) NO: K222031(Traditional)
ATTN: Jing  Huang                 PHONE NO : 86 136 56146897 
No. 12, Jinfeng Road West Taihu ScSE DECISION MADE: 28-OCT-22
Changzhou  CN 213149              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEUROMARK System
Neurent Medical                   510(k) NO: K222032(Traditional)
ATTN: Karen E. Peterson           PHONE NO : 651 3984341 
1 Oran Point, Main Street, OranmorSE DECISION MADE: 26-OCT-22
Galway  IE H91D7X2                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
Elekta Solutions AB               510(k) NO: K222047(Traditional)
ATTN: Helena  Skar                PHONE NO : 46 076 8543688 
Kungstensgatan 18 Box 7593        SE DECISION MADE: 26-OCT-22
Stockholm  SE SE-10393            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
WRP Asia Pacific SDN. BHD.        510(k) NO: K222058(Traditional)
ATTN: Siti Iylia Zarith Bt Hasan  PHONE NO : 60 3 87061486 
Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 22-OCT-22
Sepang  MY 43900                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Alma Soprano Titanium
Alma Lasers Inc.                  510(k) NO: K222064(Traditional)
ATTN: Jessica  Rivera-Montejo     PHONE NO : 224___ 3772000___ 
485 Half Day Rd Ste 100           SE DECISION MADE: 12-OCT-22
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Durex Penck III Regular
RB Health (US) LLC                510(k) NO: K222068(Traditional)
ATTN: Kyle  Prince                PHONE NO : 862 3250012 
399 Interpace Parkway             SE DECISION MADE: 12-OCT-22
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoNaut
Therenva SAS                      510(k) NO: K222070(Traditional)
ATTN: Audrey  Gallois             PHONE NO : 00 33 972522921 
74F rue de Paris                  SE DECISION MADE: 25-OCT-22
Rennes  FR 35000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
Zibo Langu New Material Technology510(k) NO: K222074(Traditional)
ATTN: Wang  Qidong                PHONE NO : 0086 533 7856083 
Room 1120-2, Entreperneurship IncuSE DECISION MADE: 17-OCT-22
Zibo  CN 255400                   510(k) STATEMENT
                                                    

DEVICE: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy                 510(k) NO: K222079(Traditional)
ATTN: Divya  Sekar                PHONE NO : 669 2044851 
5900 Optical Ct                   SE DECISION MADE: 11-OCT-22
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
SG Healthcare CO LTD              510(k) NO: K222080(Traditional)
ATTN: Byung Ju Kang               PHONE NO : 82 2 4496908 
10, Yangnyeong-ro, Yangpyeong-ri, SE DECISION MADE: 06-OCT-22
Seoul  KR 17408                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ID-510 iRestore Elite
Freedom Laser Therapy, Inc.       510(k) NO: K222081(Traditional)
ATTN: Wei-Chih  Chen              PHONE NO : 714 6699888 
16782 Von Karman Avenue, Unit 15  SE DECISION MADE: 13-OCT-22
Irvine CA  92606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Standard Tapered Bougie, 38 Fr.
Standard Bariatrics, Inc.         510(k) NO: K222085(Traditional)
ATTN: Michelle  Schnell           PHONE NO : 513 7026083 
4362 Glendale Milford Road        SE DECISION MADE: 31-OCT-22
Cincinnati OH  45242              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SCIg60 Infusion System
EMED Technologies Corporation     510(k) NO: K222087(Traditional)
ATTN: Olena  Whalen               PHONE NO : 916 9320071 
1262 Hawks Flight Court Suite 200 SE DECISION MADE: 13-OCT-22
El Dorado Hills CA  95762         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Abiomed 14Fr Low Profile Introducer Set
Abiomed Inc.                      510(k) NO: K222113(Traditional)
ATTN: Ken  Ryder                  PHONE NO : 
22 Cherry Hill Drive              SE DECISION MADE: 13-OCT-22
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soft Palate Elevator
The TMJ Clinic, PC.               510(k) NO: K222127(Abbreviated)
ATTN: John  Summer                PHONE NO : 503 2417353 
833 SW 11th Ave. # 810            SE DECISION MADE: 24-OCT-22
Portland OR  97205                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Blood Collection Needle (Without Needle Holder)
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K222141(Traditional)
ATTN: Bingyi  Xiang               PHONE NO : 86 556 5129666 
No. 2 Guanyin Road, Economic DevelSE DECISION MADE: 21-OCT-22
Anqing  CN 246400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHO Photocoagulator
Norlase                           510(k) NO: K222157(Traditional)
ATTN: Jan  Forstberg              PHONE NO : 45 40 109302 
Brydehusvej 13                    SE DECISION MADE: 11-OCT-22
Ballerup  DK DK-2750              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-Z Chek Chlorine Residual Test Strips (K100-0101B)
Reprocessing Products Corporation 510(k) NO: K222167(Traditional)
ATTN: Dave  Cox                   PHONE NO : 520 8885551 
1643 W. MODERN COURT              SE DECISION MADE: 18-OCT-22
TUCSON AZ  85705                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
SuperSonic Imagine                510(k) NO: K222191(Traditional)
ATTN: Shalyna  Bansropun          PHONE NO : 33 4 13102428 
Zac de l`enfant 135 rue Emilien GaSE DECISION MADE: 28-OCT-22
Aix en Provence  FR 13290         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Collagen P.I.N. (Percutaneous Induction Needling)
Induction Therapies LLC           510(k) NO: K222199(Traditional)
ATTN: Amelia  Aslam               PHONE NO : 502 5943116 
1920 Stanley Gault Parkway, Suite SE DECISION MADE: 21-OCT-22
Louisville KY  40223              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biological Feedback and Stimulation System
Medlander Medical Technology Inc. 510(k) NO: K222201(Traditional)
ATTN: Wang  Wang                  PHONE NO : 86 159 96375859 
Building 5, Acceleration Zone, NanSE DECISION MADE: 21-OCT-22
Nanjing  CN 211100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DualXSLIM(R) T/PLIF
Amplify Surgical, Inc.            510(k) NO: K222203(Traditional)
ATTN: Erickson  Nathan            PHONE NO : 435 2379524 
9272 Jeronimo Rd Suite 107B       SE DECISION MADE: 18-OCT-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cold Sore Device (Model: QPZ-01)
Light Tree Ventures Europe B.V.   510(k) NO: K222205(Traditional)
ATTN: Alain  Dijkstra             PHONE NO : 86 135 103787481 
Laan van Ypenburg 108, 2497 GC, ThSE DECISION MADE: 07-OCT-22
Hague  NL                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical Inc.               510(k) NO: K222209(Traditional)
ATTN: Subhadra  Elango            PHONE NO : 1 442 2326086 
2210 Faraday Ave, Suite 100       SE DECISION MADE: 17-OCT-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPD Dental Implant Abutments
Implant Protesis Dental 2004 S.L  510(k) NO: K222215(Traditional)
ATTN: Francesc  Fumanal           PHONE NO : 34 93 2788491 
Cami del Mig. 71.                 SE DECISION MADE: 21-OCT-22
Mataro  ES 08302                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S.I.N. Dental Implant System
S.I.N. - Sistema de Implante Nacio510(k) NO: K222231(Traditional)
ATTN: Denise  Domiciano           PHONE NO : 5511 2169 3000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 27-OCT-22
Sao Paulo  BR 03340-000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex 2.4 mm Volar Distal Radius Plate System
Arthrex Inc.                      510(k) NO: K222267(Traditional)
ATTN: Stacy  Valdez               PHONE NO : 1_____ 239 6435553 72010
1370 Creekside Boulevard          SE DECISION MADE: 03-OCT-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DESS Dental Smart Solutions
Terrats Medical SL                510(k) NO: K222269(Traditional)
ATTN: Roger  Terrats              PHONE NO : 34 935 646006 
Carrer Mogoda 75-99               SE DECISION MADE: 26-OCT-22
Barbera del Valles  ES 08210      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
Globus Medical Inc.               510(k) NO: K222270(Traditional)
ATTN: Kelly  Baker                PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 21-OCT-22
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONDUIT Cages; FIBERGRAFT BG Putty
DePuy Spine                       510(k) NO: K222276(Traditional)
ATTN: Philip  Desjardins          PHONE NO : 202 5891005 
325 Paramount Dr.                 SE DECISION MADE: 15-OCT-22
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intracept Intraosseous Nerve Ablation System
Relievant Medsystems, Inc.        510(k) NO: K222281(Traditional)
ATTN: Thomas A. Slater            PHONE NO : 1 650 3681000 135
1230 Midas Way, Suite 200         SE DECISION MADE: 26-OCT-22
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
Hospital Equipment Manufacturing C510(k) NO: K222282(Traditional)
ATTN: Himanshu  Sachdeva          PHONE NO : 91 120 4088888 
A19/A20, Sector 7                 SE DECISION MADE: 27-OCT-22
Noida  IN 201301                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
Applied Medical Resources Corporat510(k) NO: K222284(Special)
ATTN: Blake  Stacy                PHONE NO : 949 7138163 
22872 Avenida Empresa             SE DECISION MADE: 14-OCT-22
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DESS Dental Smart Solutions
Terrats Medical SL                510(k) NO: K222288(Traditional)
ATTN: Roger  Terrats              PHONE NO : 34 935 646006 
Carrer Mogoda 75-99               SE DECISION MADE: 27-OCT-22
Barberà del Vallès  ES 08210      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
Onetexx SDN BHD                   510(k) NO: K222298(Traditional)
ATTN: Freddy  Low                 PHONE NO : 605 8070666 
No 73-86, JLN Logam 5, PerindustriSE DECISION MADE: 18-OCT-22
Kamunting  MY 34600               510(k) STATEMENT
                                                    

DEVICE: Unistik® Pro
Owen Mumford Ltd                  510(k) NO: K222303(Traditional)
ATTN: Darren  Mansell             PHONE NO : 01 993___ 812021 
Owen Mumford, Brook Hill, WoodstocSE DECISION MADE: 25-OCT-22
Woodstock  GB OX20 ITU            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fresenius Liberty Select Cycler
Fresenius Medical Care Renal Thera510(k) NO: K222318(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 9969103 
920 Winter Street                 SE DECISION MADE: 31-OCT-22
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
Luoyang Sunmed Devices Co., Ltd.  510(k) NO: K222335(Traditional)
ATTN: Tian  Qian                  PHONE NO : 86 18637 911566 
No. 8 Huaxia Road, Hi-Tech Zone, LSE DECISION MADE: 11-OCT-22
Luoyang  CN 471003                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JR MEDIC
JR Engineering & Medical Technolog510(k) NO: K222348(Abbreviated)
ATTN: Ganesan  Subramaniam        PHONE NO : 603 60 572081 
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 27-OCT-22
Hulu Selangor  MY 44200           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JR MEDIC  Nitrile Examination Gloves Powder Free (Orange, Purple)
JR Engineering & Medical Technolog510(k) NO: K222349(Abbreviated)
ATTN: Ganesan  Subramaniam        PHONE NO : 603 60 572081 
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 21-OCT-22
Hulu Selangor  MY 44200           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elastic Traction System
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K222354(Traditional)
ATTN: Sally  He                   PHONE NO : 86 25 58646395 
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 03-OCT-22
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI-Rad Companion (Musculoskeletal)
Siemens Medical Solutions USA, Inc510(k) NO: K222361(Traditional)
ATTN: Kira  Kuzmenchuk            PHONE NO : 1484 9019471 
40 Liberty Blvd.                  SE DECISION MADE: 20-OCT-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leltek Ultrasound Imaging System (Model: LU700 Series)
Leltek Inc                        510(k) NO: K222365(Traditional)
ATTN: Paul  Chang                 PHONE NO : 886 2 29137577 
6F.-3, No. 293, Sec. 1, Beixin Rd.SE DECISION MADE: 25-OCT-22
New Taipei City  TW 23147         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EsoCheck Cell Collection Device
Lucid Diagnostics, Inc.           510(k) NO: K222366(Traditional)
ATTN: Lishan  Aklog               PHONE NO : 212 9494319 
One Grand Central Place, Suite 460SE DECISION MADE: 26-OCT-22
New York NY  10165                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PURE Laser
Endymed Medical, Ltd.             510(k) NO: K222369(Traditional)
ATTN: Ohad  Fisher                PHONE NO : 972 4 6309100 
12 Leshem St. North Industrial ParSE DECISION MADE: 07-OCT-22
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
Shandong Lianfa Medical Plastic Pr510(k) NO: K222376(Traditional)
ATTN: Charles  Shen               PHONE NO : 086___ 531 61328777 
No. 1 Shuangshan Sanjian Road, ZhaSE DECISION MADE: 03-OCT-22
Jinan  CN 250200                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TriVerse Total Knee Replacement System
Signature Orthopaedics Pty Ltd.   510(k) NO: K222380(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 04-OCT-22
Lane Cove West  AU 2066           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evo® sEEG System
NeuroOne Medical Technologies Corp510(k) NO: K222404(Traditional)
ATTN: Debra  Kridner              PHONE NO : 763 4434476 
7599 Anagram Drive                SE DECISION MADE: 20-OCT-22
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
NeoCoil, LLC                      510(k) NO: K222407(Special)
ATTN: Katie  Gonzalez             PHONE NO : 262 5226124 
N27 W23910A Paul Road             SE DECISION MADE: 14-OCT-22
Pewaukee WI  53072                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rexious Spinal Fixation System
Dio Medical Corporation           510(k) NO: K222415(Traditional)
ATTN: Milan  George               PHONE NO : 877 3945407 102
2100 Campus Lane, Suite 100       SE DECISION MADE: 25-OCT-22
East Norriton PA  19403           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nuvola
Gruppo Europeo Ortodonzia srl     510(k) NO: K222418(Traditional)
ATTN: Massimiliano  Bucceri       PHONE NO : 39 06 72671754 
via Cropani, 118 A/B              SE DECISION MADE: 07-OCT-22
Rome  IT 00173                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protect-It Custom Fit Dental Guard
DOC Brands, Inc.                  510(k) NO: K222424(Traditional)
ATTN: Sean  Stubbs                PHONE NO : 865___ 6043525 
407 E. Lancaster Avenue           SE DECISION MADE: 07-OCT-22
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRIMA TT Glenoid
LimaCorporate S.p.A.              510(k) NO: K222427(Traditional)
ATTN: Michela  Zanotto            PHONE NO : 39 043 2945511 
Via Nazionale 52                  SE DECISION MADE: 06-OCT-22
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: b-ONER MOBIO Total Knee System
b-ONE ORTHO, Corp.                510(k) NO: K222431(Traditional)
ATTN: Allison  Gecik              PHONE NO : 973 9658940 
3 Wing Drive Suite #259           SE DECISION MADE: 06-OCT-22
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal Device, Model(s): KCA423,  KCA437, KCA439
Hunan Guangye Biotechnology Co., L510(k) NO: K222432(Traditional)
ATTN: Eileen  Li                  PHONE NO : 86 0755 89373426 
Room A701, Jinhong Park IncubationSE DECISION MADE: 11-OCT-22
Changsha City  CN 410006          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renamel® Microhybrid ;Renamel® Flowable Microhybrid
Cosmedent, Inc                    510(k) NO: K222435(Traditional)
ATTN: Gary  Chuven                PHONE NO : 312 644958617_ 
401 N Michigan Ave, Suite 2500    SE DECISION MADE: 11-OCT-22
Chicago IL  60611                 510(k) STATEMENT
                                                    

DEVICE: UNITY Sacroiliac Joint Fixation System
Dio Medical Corporation           510(k) NO: K222448(Traditional)
ATTN: Milan  George               PHONE NO : 716 4655551 
2100 Campus Lane Suite 100        SE DECISION MADE: 13-OCT-22
East Norriton PA  19403           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3Dicom MD
Singular Health Pty Ltd           510(k) NO: K222470(Traditional)
ATTN: James  Hill                 PHONE NO : 61 81300 167795 
3/26 Railway Road                 SE DECISION MADE: 25-OCT-22
Subiaco  AU 6008                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
Medos-International, SARL         510(k) NO: K222473(Traditional)
ATTN: Denielle  Smith             PHONE NO : 978 5388842 
Chemin Blanc 38                   SE DECISION MADE: 13-OCT-22
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mobility Scooter, Model: W3331F
Zhejiang Innuovo Rehabilitation De510(k) NO: K222495(Traditional)
ATTN: Leo  Zheng                  PHONE NO : 86 183 58936043 
No.196 Industry Road, Hengdian MovSE DECISION MADE: 17-OCT-22
Dongyang  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
Humanwell Healthcare Group Medical510(k) NO: K222498(Traditional)
ATTN: Aixue  Yao                  PHONE NO : 186 2772 6855______ 
14th F, 1500# Century Avenue      SE DECISION MADE: 26-OCT-22
Wuhan  CN                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CurvaFix IM System
CurvaFix, Inc.                    510(k) NO: K222505(Traditional)
ATTN: Steve  Dimmer               PHONE NO : 206 3274284___ 
1406 Place NE Suite 107           SE DECISION MADE: 27-OCT-22
Bellevue WA  98007                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S.I.N. Instrument Kits
S.I.N. – Sistema de Implante Nacio510(k) NO: K222514(Traditional)
ATTN: Denise  Domiciano           PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 27-OCT-22
São Paulo  BR 03340-000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FaSet Fixation System
Dio Medical Corporation           510(k) NO: K222515(Traditional)
ATTN: Milan  George               PHONE NO : 877 3945407 102
2100 Campus Lane, Suite 100       SE DECISION MADE: 05-OCT-22
East Norriton PA  19403           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
Shenzhen Ishine Technology Company510(k) NO: K222537(Traditional)
ATTN: Chaohui  An                 PHONE NO : 86____ 138 23508753 
Room 213 Building 4, No.45, Makan SE DECISION MADE: 14-OCT-22
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric nasal aspirator
Shenzhen XinLianFeng Technology CO510(k) NO: K222547(Traditional)
ATTN: Ma  Qiang                   PHONE NO : 86____ 135 90244726 
No.5, Tongxi Road, Pingdong CommunSE DECISION MADE: 20-OCT-22
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Persona Personalized Knee System
Zimmer, Inc.                      510(k) NO: K222566(Traditional)
ATTN: Lauren  Ricker              PHONE NO : 574 3067578___ 
1800 W Center Street              SE DECISION MADE: 17-OCT-22
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System
Dio Medical Corporation           510(k) NO: K222572(Traditional)
ATTN: Milan  George               PHONE NO : 877 3945407 102___
2100 Campus Lane, Suite 100       SE DECISION MADE: 18-OCT-22
East Norriton PA  19403           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stela Automix System
SDI Limited                       510(k) NO: K222581(Traditional)
ATTN: Quynh  Jewell               PHONE NO : 61 3 87277107 
3-15 Brunsdon Street, Bayswater   SE DECISION MADE: 28-OCT-22
Melbourne  AU 3153                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stela Capsule System
SDI Limited                       510(k) NO: K222583(Traditional)
ATTN: Quynh  Jewell               PHONE NO : 61 3 87277107 
3-15 Brunsdon Street, Bayswater   SE DECISION MADE: 28-OCT-22
Melbourne  AU 3153                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Pneumonia Panel plus
BioFire Diagnostics, LLC          510(k) NO: K222601(Special)
ATTN: Kevin  Bourzac              PHONE NO : 801 7366354 1358
515 Colorow Drive                 SE DECISION MADE: 27-OCT-22
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VASSALLO GT EXT
Filmecc Co. Ltd.                  510(k) NO: K222631(Traditional)
ATTN: Toshiya  Osawa              PHONE NO : 81 52 7681212 
1703 Wakita-cho, Moriyama-ku      SE DECISION MADE: 26-OCT-22
Nagoya-shi  JP 463-0024           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UHR Bipolar Implants, Restoration GAP II Implants
Howmedica Osteonics Corp., dba Str510(k) NO: K222632(Traditional)
ATTN: Margaret  Klippel           PHONE NO : 201 8315559 
325 Corporate Drive               SE DECISION MADE: 21-OCT-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Sirius Medical Systems B.V.       510(k) NO: K222643(Special)
ATTN: Bram  Schermers             PHONE NO : 
High Tech Campus 41               SE DECISION MADE: 19-OCT-22
Eindhoven  NL 5656AE              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
Smith+Nephew, Inc                 510(k) NO: K222653(Traditional)
ATTN: Lilian  Hren                PHONE NO : 901 5588200 
1450 Brooks Rd                    SE DECISION MADE: 28-OCT-22
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEBO Wound Dressing
MEBO Life Science Inc.            510(k) NO: K222657(Special)
ATTN: Sidney  Hong                PHONE NO : 626___ 3487978 
325 North Puente Street # A       SE DECISION MADE: 18-OCT-22
Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea CT Cardiac Analysis
Canon Medical Informatics, Inc.   510(k) NO: K222662(Special)
ATTN: Jay  Vaishnav               PHONE NO : 952___ 4879769 
5850 Opus Parkway, Suite 300      SE DECISION MADE: 14-OCT-22
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mobility+ Enteral Feeding System
Rockfield Medical                 510(k) NO: K222678(Traditional)
ATTN: Orla  Connaughton           PHONE NO : 353 91 763000 
iHub GMIT, Dublin Road            SE DECISION MADE: 27-OCT-22
Galway  IE H91 DCH9               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Perfit FS Dental Zirconia Fully Sintered Block
Vatech Acucera, Inc.              510(k) NO: K222686(Special)
ATTN: Kwon Kyung Wook             PHONE NO : 82 31 80051851 
2544, Nambuk-daero, Idong-eup, CheSE DECISION MADE: 06-OCT-22
Yongin-si  KR 17138               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUVIS-spine
Curexo, Inc.                      510(k) NO: K222698(Special)
ATTN: Jungeun  Park               PHONE NO : 82 31 7887935 
577, Gangnam-Daero, Seocho-Gu     SE DECISION MADE: 07-OCT-22
Seoul  KR 06530                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tibial baseplate, Tibial insert
United Orthopedic Corporation     510(k) NO: K222700(Special)
ATTN: Lois  Ho                    PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park   SE DECISION MADE: 06-OCT-22
Hsinchu  TW 30075                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
Guang Dong Kingfa Sci. & Tech.Co.,510(k) NO: K222714(Special)
ATTN: Xiaoge  Yu                  PHONE NO : 86 135 70952157 
No. 28 Delong Ave., Shijiao Town, SE DECISION MADE: 07-OCT-22
Qingyuan  CN 511545               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CL24N
WIDE Corporation                  510(k) NO: K222717(Traditional)
ATTN: YeoJin  Yun                 PHONE NO : 82 31 2181675 
15F, The First Tower III, 602, DonSE DECISION MADE: 31-OCT-22
Hwaseong-Si  CN 18469             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (HK) Limited   510(k) NO: K222721(Traditional)
ATTN: Alvin  Ho                   PHONE NO : 60 128 265625____ 
26th Floor, Beautiful Group Tower,SE DECISION MADE: 18-OCT-22
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CW60N
WIDE Corporation                  510(k) NO: K222722(Traditional)
ATTN: YeoJin  Yun                 PHONE NO : 82 31 2181675 
15F, The First Tower III, 602, DonSE DECISION MADE: 31-OCT-22
Hwaseong-Si  KR 18469             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
Shanghai AnQing Medical Instrument510(k) NO: K222737(Special)
ATTN: Shuwen  Fan                 PHONE NO : 86 021 61117375 
3 & 4 Floor, No.2 Building, 366 HuSE DECISION MADE: 05-OCT-22
Shanghai  CN 201201               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Route 92 Medical Full Length 070 Access System
Route 92 Medical, Inc.            510(k) NO: K222743(Special)
ATTN: Kirsten  Valley             PHONE NO : 650 2798427 
155 Bovet Road, Suite 100         SE DECISION MADE: 04-OCT-22
San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sol-M Luer Lock Syringe
Sol-Millennium Medical Inc.       510(k) NO: K222744(Special)
ATTN: Ying  Zhao                  PHONE NO : 919 3242268 
315 Shawnee North Dr. Suite 100   SE DECISION MADE: 11-OCT-22
Suwanee GA  30024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
Responsive Arthroscopy LLC        510(k) NO: K222763(Special)
ATTN: Garrett  Ahlborg            PHONE NO : 612 5326800___ 
701 N. 3rd Street, Suite 208      SE DECISION MADE: 13-OCT-22
Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafeBreak Vascular
Lineus Medical, LLC               510(k) NO: K222791(Special)
ATTN: Vance  Clement              PHONE NO : 
179 North Church Ave, Suite 202   SE DECISION MADE: 16-OCT-22
Fayetteville AZ  72701            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WavelinQ™ Generator
C.R. Bard, Inc.                   510(k) NO: K222793(Special)
ATTN: Jakob  Wells                PHONE NO : 602___ 8305382 
1625 West 3rd Street              SE DECISION MADE: 17-OCT-22
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-Pac Expandable Lumbar Cage System
Expanding Innovations, inc        510(k) NO: K222797(Special)
ATTN: Robert  Jaramillo           PHONE NO : 925___ 8192257 
110 Pioneer Way, Ste 1            SE DECISION MADE: 14-OCT-22
Mountain View CA  94041-1519      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEMA Elbow system - Line extension
LimaCorporate S.p.A.              510(k) NO: K222807(Traditional)
ATTN: Marco  Tallerico            PHONE NO : 390 432 945511 
Via Nazionale 52                  SE DECISION MADE: 26-OCT-22
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Firefly Imaging System
Intuitive Surgical Inc.           510(k) NO: K222827(Special)
ATTN: Melissa  Gonzalez           PHONE NO : 408 5238684 
1266 Kifer Road                   SE DECISION MADE: 20-OCT-22
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V-Patch Cardiac Monitor
Shandong CoreCare Technology Limit510(k) NO: K222842(Traditional)
ATTN: Cao  Cheng                  PHONE NO : 86____ 186 10294350 
Suite 801-2, Incubator Phase I, InSE DECISION MADE: 20-OCT-22
Jinan  CN                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Radiography CXDI-Pro, Digital Radiography D1
Canon, Inc.                       510(k) NO: K222855(Special)
ATTN: Mr. Akira  Hirai            PHONE NO : 81 3 37582111 
9-1 Imaikami-Cho, Nakahara-Ku     SE DECISION MADE: 17-OCT-22
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMAVAC 100 Sustained Vacuum System
SOMAVAC Medical Solutions, Inc.   510(k) NO: K222856(Special)
ATTN: Phil  Ryan                  PHONE NO : 901 2122198 
3144 Stage Post Rd Unit 101       SE DECISION MADE: 19-OCT-22
Bartlett TN  38133                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mercu 1717V
iRay Technology Taicang Ltd.      510(k) NO: K222886(Special)
ATTN: Junjie  Qian                PHONE NO : 86 0512 53690872 
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 20-OCT-22
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RADIANCE ULTRA 32" 4K ZEROWIRE DUO
NDS Surgical Imaging, LLC.        510(k) NO: K222890(Special)
ATTN: Jim  Leng                   PHONE NO : 408 3100832 
100 Paramount Drive, Suite 101    SE DECISION MADE: 19-OCT-22
Sarasota FL  34232                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Examination Glove
Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K222937(Traditional)
ATTN: Guo  Hua                    PHONE NO : 86 134 85097856 
No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 01-OCT-22
Suqian  CN 223800                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2008T BlueStar Hemodailysis Machine
Fresenius Medical Care Renal Thera510(k) NO: K222952(Traditional)
ATTN: Denise M Oppermann          PHONE NO : 781 9969103 
920 Winter Street                 SE DECISION MADE: 27-OCT-22
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cirq Arm System (2.0);Alignment System Spine
Brainlab AG                       510(k) NO: K222966(Special)
ATTN: Sadwini  Suresh             PHONE NO : 49 899 915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 27-OCT-22
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K222968(Special)
ATTN: Janine F Reyes              PHONE NO : 714 6697853 
1385 Shimoishigami                SE DECISION MADE: 25-OCT-22
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Vinyl Examination Gloves
Jiangxi Handspro Products Solution510(k) NO: K223008(Traditional)
ATTN: Jun  Yin                    PHONE NO : 86 186 16636918 
Chuangye Avenue, Fenglin IndustriaSE DECISION MADE: 08-OCT-22
Jiujiang City  CN 330406          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VS3-Iridium System (VS3-IR)
Visionsense Ltd.                  510(k) NO: K223020(Special)
ATTN: Guy  Wroclawski             PHONE NO : 972 50 2049052 
20 Hamagshimim St.                SE DECISION MADE: 28-OCT-22
Petach Tikva, Hamerkaz  IL 4934829510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viz LVO ContaCT
Viz.ai, Inc.                      510(k) NO: K223042(Special)
ATTN: Gregory  Ramina             PHONE NO : 239 8983105 
201 Mission St 12th Floor         SE DECISION MADE: 21-OCT-22
San Francisco CA  94105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzRay Air 2 Wall (Model: VEX-S350W)
Vatech Co., Ltd                   510(k) NO: K223058(Special)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799492 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 26-OCT-22
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DigiX FDX
Allengers Medical Systems Limited 510(k) NO: K223060(Special)
ATTN: Sanjeev K Marjara           PHONE NO : 91 1762 282600 
FDA Hall Unit-2, Bhankarpur, MubarSE DECISION MADE: 26-OCT-22
Derabassi, Distt. Mohali  IN 14050510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALLY II Uterine Positioning System™ (UPS)
CooperSurgical, Inc.              510(k) NO: K223064(Special)
ATTN: Yin  Huang                  PHONE NO : 475 2399538 
95 Corporate Drive                SE DECISION MADE: 28-OCT-22
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
Adcura, Inc.                      510(k) NO: K223065(Special)
ATTN: Andrew  Rogers              PHONE NO : 1_____ 952 4000407 
11010 Prairie Lakes Dr Ste 375    SE DECISION MADE: 26-OCT-22
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Remi Robotic Navigation System
Fusion Robotics, LLC              510(k) NO: K223070(Special)
ATTN: Sarah  Braun                PHONE NO : 423 8384454 
168 Centennial Parkway, Unit 170  SE DECISION MADE: 28-OCT-22
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stage
SpinTech, Inc.                    510(k) NO: K223079(Special)
ATTN: Rana El Hachem              PHONE NO : 248 7126789 
30200 Telegraph Road Suite 140    SE DECISION MADE: 28-OCT-22
Bingham Farms MI  48025           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bakri Essential Postpartum Balloon
Cook Incorporated                 510(k) NO: K223098(Special)
ATTN: Ian  Herman                 PHONE NO : 812 3353575 104034
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 28-OCT-22
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
PT. Sintong Unigolden Glove       510(k) NO: K223235(Abbreviated)
ATTN: MP  Vivekanandan            PHONE NO : 62 62 3533339 
Jl. Lintas Sumatera, Kel. Hessa PeSE DECISION MADE: 26-OCT-22
Kota Kisaran  ID 21272            510(k) SUMMARY AVAILABLE FROM FDA
                                                    


                TOTAL 510(k)s THIS PERIOD   295                                     
                TOTAL WITH SUMMARIES        282                                     
                TOTAL WITH STATEMENTS        13
                                      
 
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