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  1. 510(k) Clearances

April 2022 510(K) Clearances

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


DEVICE: V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
Helena Laboratories, Corp.        510(k) NO: K192931(Traditional)
ATTN: Justin  Padia               PHONE NO : 409 8423714 
1530 Lingbergh Drive              SE DECISION MADE: 19-APR-22
Beaumont TX  77707                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
TaiDoc Technology Corporation     510(k) NO: K200946(Traditional)
ATTN: Jacky  Chou                 PHONE NO : 886 2662 58188 
6F, No.127, Wugong 2nd Rd., Wugu DSE DECISION MADE: 05-APR-22
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zeus IFA ANA HEp-2 Test System, Zeus dIFine
Zeus Scientific, Inc.             510(k) NO: K201956(Traditional)
ATTN: Mark J. Kopnitsky           PHONE NO : 908 2434904 
PO Box 38                         SE DECISION MADE: 29-APR-22
Raritan NJ  08869                 510(k) STATEMENT
                                                    

DEVICE: Plasmage System
Brera Medical Inc                 510(k) NO: K202106(Traditional)
ATTN: Felix  Feldchtein           PHONE NO : 508 8751292 
19 Kramas Lane                    SE DECISION MADE: 06-APR-22
Northwood NH  03261               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oxygen Concentrator
Foshan MIC Medical Technology Co.,510(k) NO: K202389(Traditional)
ATTN: Wu  Huahong                 PHONE NO : 86 757 86678238 
U501-1,503, 5F, No.7 Building, ZonSE DECISION MADE: 08-APR-22
Foshan  CN 528200                 510(k) STATEMENT
                                                    

DEVICE: MTM301 Blood Glucose and Ketone Monitoring System
Apex Biotechnology Corp.          510(k) NO: K202534(Traditional)
ATTN: Lisa  Liu                   PHONE NO : 011 886 35641952 
No. 7, Li-Hsin Road V, Hsinchu SciSE DECISION MADE: 06-APR-22
Hsinchu  TW 30078                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortholock Anchorage Devices
Craniofacial Technologies, Inc.   510(k) NO: K202691(Traditional)
ATTN: Kevin  Kaveh                PHONE NO : 949 3956251 
98 Buckskin Road                  SE DECISION MADE: 28-APR-22
West Hills CA  91307              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alinity m STI Assay
Abbott Molecular, Inc.            510(k) NO: K202977(Traditional)
ATTN: Stacy  Ferguson             PHONE NO : 224 3617449 
1300 E. Touhy                     SE DECISION MADE: 29-APR-22
Des Plains IL  60018              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClariPulmo
ClariPi Inc.                      510(k) NO: K203783(Traditional)
ATTN: Hyun-Sook  Park             PHONE NO : 82 8 7413014 
3F, 70-15, Ihwajang-gil           SE DECISION MADE: 06-APR-22
Seoul  KR 03088                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bendit21 Microcatheter
Bend It Technologies Ltd          510(k) NO: K203842(Traditional)
ATTN: Simona  Beilin-Nissan       PHONE NO : 972 3 6747377 
25 Basel Street                   SE DECISION MADE: 13-APR-22
Petach Tikva  IL 4951038          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoNextions TR Tendon Repair System
CoNextions Medical                510(k) NO: K203855(Traditional)
ATTN: Matthew  Swift              PHONE NO : 385 3511461 
150 North Wright Brothers Drive, SSE DECISION MADE: 22-APR-22
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A  (Model: with/without Select Band Imaging (SBI))
Saneso Inc.                       510(k) NO: K210052(Traditional)
ATTN: Nitesh  Ratnakar            PHONE NO : 412 2507621 
One Oxford Center, 301 Grant StreeSE DECISION MADE: 01-APR-22
Pittsburgh PA  15219              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: visor2 system
Eemagine Medical Imaging Solutions510(k) NO: K210109(Traditional)
ATTN: Maarten Van De Velde        PHONE NO : 
Gubenerstr. 47, Fabrik D-10243    SE DECISION MADE: 08-APR-22
Berlin  DE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cannulated Compression Device System
Orthopedic Designs North America, 510(k) NO: K210146(Traditional)
ATTN: Robin  Wilson               PHONE NO : 813 4434905 
5912 Breckridge Parkway Suite F   SE DECISION MADE: 13-APR-22
Tampa FL  33610                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
Flomak Tekstil Makine Muh. Mum. Ta510(k) NO: K210148(Traditional)
ATTN: Alaattin  Saz               PHONE NO : 90 212 4221350 
Beysan Sanayi Sitesi, Dereboyu CadSE DECISION MADE: 13-APR-22
Istanbul  TR 34524                510(k) STATEMENT
                                                    

DEVICE: Waterlase iPLus
Biolase, Inc.                     510(k) NO: K210183(Traditional)
ATTN: Katy  Nennig                PHONE NO : 949 3611200 
27042 Towne Centre Drive, Suite 27SE DECISION MADE: 21-APR-22
FootHill Ranch CA  92610          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpeedCath Compact Male
Coloplast                         510(k) NO: K210250(Traditional)
ATTN: Delaney  McDougal           PHONE NO : 612 3808034 
1601 West River Road North        SE DECISION MADE: 26-APR-22
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ManaSport
ManaMed, Inc.                     510(k) NO: K210284(Traditional)
ATTN: Trevor  Theriot             PHONE NO : 702 7811117 
5240 W. Charleston Blvd.          SE DECISION MADE: 26-APR-22
Las Vegas NV  89146               510(k) STATEMENT
                                                    

DEVICE: BIOTEQ Drainage Catheter BT-PDS-series
Bioteque Corporation              510(k) NO: K210419(Traditional)
ATTN: Stella  Hsu                 PHONE NO : 886 2 27510269 1348
5F-6, No. 23, Sec. 1, Chang’an E. SE DECISION MADE: 13-APR-22
Taipei City  TW 104               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
Thayer Medical Corporation        510(k) NO: K210558(Traditional)
ATTN: Christine  Woeppel          PHONE NO : 520 7905393 
4575 S. Palo Verde Road, Suite 337SE DECISION MADE: 01-APR-22
Tucson AZ  85714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Onera Sleep Test System (Onera STS)
Onera B.V.                        510(k) NO: K210593(Traditional)
ATTN: Ruben  de Francisco Martin  PHONE NO : 31 0 403082177 
Torenallee 42-54                  SE DECISION MADE: 06-APR-22
Eindhoven  NL 5617BD              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MCL 31 Dermablate System
Asclepion Laser Technologies GmbH 510(k) NO: K210634(Traditional)
ATTN: Dania Di Pietro Paolo       PHONE NO : 49 3641 7700201 
Bruesseler Strasse 10             SE DECISION MADE: 13-APR-22
Jena  DE 07747                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Extended Reservoir
Medtronic MiniMed, Inc.           510(k) NO: K210714(Traditional)
ATTN: Prerna  Singh               PHONE NO : 818 5764517 
18000 Devonshire Street           SE DECISION MADE: 06-APR-22
Northridge CA  91325              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
GRI-Alleset, Inc                  510(k) NO: K210860(Traditional)
ATTN: Martin  Paugh               PHONE NO : 678 5238977 
4142 Industry Way                 SE DECISION MADE: 07-APR-22
Flowery Branch GA  30542          510(k) STATEMENT
                                                    

DEVICE: ZENEX Implant System
Izenimplant Co., Ltd.             510(k) NO: K211090(Traditional)
ATTN: Mi-Kyung  Kwon              PHONE NO : 82 31 6620657 
1, 2Dong, 26-32, Suworam 4-gil, SeSE DECISION MADE: 13-APR-22
Pyeongtaek-si  KR 17703           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
Huizhou Foryou Medical Devices CO.510(k) NO: K211123(Traditional)
ATTN: Huiqi  Huang                PHONE NO : 86 0752 5302185 
North Shangxia Rd., Dongjiang Hi-tSE DECISION MADE: 22-APR-22
Huizhou  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Green OR Reprocessed Aquamantys Bipolar Sealer
Green OR, LLC.                    510(k) NO: K211203(Traditional)
ATTN: John  Zehren                PHONE NO : 312 5904358 
4200 Dahlberg Drive #300          SE DECISION MADE: 07-APR-22
Golden Valley MN  55422           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bindex BI-2
Bone Index Finland Ltd.           510(k) NO: K211350(Traditional)
ATTN: Janne  Karjalainen          PHONE NO : 358 40 7079892 
Savilahdentie 14                  SE DECISION MADE: 29-APR-22
Kuopio  FI 70700                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AngioCloud Service
AngioCloud, LLC                   510(k) NO: K211713(Traditional)
ATTN: James  Lewis                PHONE NO : 803 2691545 
1 Glenlake Parkway, Suite 200     SE DECISION MADE: 28-APR-22
Atlanta GA  30328                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RetinAI Discovery
RetinAI Medical AG                510(k) NO: K211715(Traditional)
ATTN: Enisa  Dresevic             PHONE NO : 336 29 395525 
Freiburgstrasse, 3                SE DECISION MADE: 28-APR-22
Bern  CH 3010                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altus Spine Interbody Standalone Fusion System
Altus Partners, LLC               510(k) NO: K211837(Traditional)
ATTN: Mark  Melton                PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 19-APR-22
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HD-550 Video Endoscope System
Sonoscape Medical Corp            510(k) NO: K211882(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
Room 201&2, 12th Building, ShenzheSE DECISION MADE: 01-APR-22
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermeo System
Pro3dure Medical GmbH             510(k) NO: K212017(Traditional)
ATTN: Frank  Gischer              PHONE NO : 49 02347 92005014 
Am Burgberg 13                    SE DECISION MADE: 08-APR-22
Iserlohn  DE 58642                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
3M Company                        510(k) NO: K212022(Traditional)
ATTN: Mary  Fretland              PHONE NO : 651 4612734 
3M Center, Building 275-5W-06     SE DECISION MADE: 20-APR-22
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
Fisher & Paykel Healthcare Ltd    510(k) NO: K212031(Traditional)
ATTN: Reena  Daken                PHONE NO : 64 9 5740100 
15 Maurice Paykel Place, East TamaSE DECISION MADE: 22-APR-22
Auckland  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin MetaFix™ Hip Stem
Corin USA Limited                 510(k) NO: K212069(Traditional)
ATTN: Janet  Grannells            PHONE NO : 813 9774469 
5670 W. Cypress St., Suite C      SE DECISION MADE: 07-APR-22
Tampa FL  33607                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Scooter
Anhui JBH Medical Apparatus Co.,Lt510(k) NO: K212090(Traditional)
ATTN: Dandan  Yang                PHONE NO : 86 189 36033123 
No.116 Qicang Road, Industrial parSE DECISION MADE: 22-APR-22
Chuzhou  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MediExpand Cervical Expandable VBR System
CMF Medicon Surgical Inc.         510(k) NO: K212126(Traditional)
ATTN: Matthias  Alber             PHONE NO : 904 6427500 
11200 St. Johns Industrial Pkwy N,SE DECISION MADE: 04-APR-22
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroMARK Breast Biopsy Site Marker
Devicor Medical Products, Inc.    510(k) NO: K212158(Traditional)
ATTN: Diane  Sung                 PHONE NO : 513 8942931 
300 E-Business Way, Fifth Floor   SE DECISION MADE: 21-APR-22
Cincinnati OH  45241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coala Heart Monitor
Coala Life AB                     510(k) NO: K212163(Traditional)
ATTN: Dan  Pitulia                PHONE NO : 46 8 270077 
Kalsangsgrand 10B                 SE DECISION MADE: 14-APR-22
Uppsala  SE 75319                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS and EMS Stimulation (OTC)
Changsha Yuwen Medical Equipment C510(k) NO: K212184(Traditional)
ATTN: Dahui  Chen                 PHONE NO : 86 176 70750692 
Room 2404, Kairui Building, No. 24SE DECISION MADE: 01-APR-22
Changsha  CN 410004               510(k) STATEMENT
                                                    

DEVICE: WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
OTU Medical INC.                  510(k) NO: K212202(Traditional)
ATTN: Geping  Liu                 PHONE NO : 408 7977313 
2231 A Fortune Drive              SE DECISION MADE: 13-APR-22
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dong Hai Xiang Surgical Mask
Taizhou Donghaixiang Protective Eq510(k) NO: K212203(Traditional)
ATTN: Hong  Wei                   PHONE NO : 86 137 5862711 
No.3091 Dunan Road Duqiao Town    SE DECISION MADE: 07-APR-22
Linhai  CN 317016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
Baxter Healthcare Corporation     510(k) NO: K212216(Traditional)
ATTN: Fortunato (Tito)  Aldape    PHONE NO : 224 3588599 
One Baxter Parkway                SE DECISION MADE: 01-APR-22
Deerfield IL  60015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUATERA 700
Carl Zeiss Meditec AG             510(k) NO: K212241(Traditional)
ATTN: Hans-Joachim  Miesner       PHONE NO : 49 364 1220362 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 19-APR-22
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
Brainlab AG                       510(k) NO: K212245(Traditional)
ATTN: Chiara  Cunico              PHONE NO : 49 899 915681738 
Olof-Palme-Str. 9                 SE DECISION MADE: 13-APR-22
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensuva Premium Silicone Personal Lubricant
Valencia Naturals, Inc            510(k) NO: K212260(Traditional)
ATTN: Anthony  Santoro            PHONE NO : 310 8802982 
9731 Topanga Canyon Place         SE DECISION MADE: 13-APR-22
Chatsworth CA  91311              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INT Contour
Carina Medical LLC                510(k) NO: K212274(Traditional)
ATTN: Xue  Feng                   PHONE NO : 434 2841073 
1233 Litchfield Ln                SE DECISION MADE: 08-APR-22
Lexington KY  40513               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tempo Tampon
Dong-A Pharmaceutical Co., Ltd.   510(k) NO: K212277(Traditional)
ATTN: Hyunjeong  Jang             PHONE NO : 82 2 9208289 
64 Cheonho-daero, Dongdaemun-gu   SE DECISION MADE: 21-APR-22
Seoul  KR 02587                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrocardiograph
Edan Instruments, Inc.            510(k) NO: K212278(Traditional)
ATTN: Ying  Dai                   PHONE NO : 86 152 21873029 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 07-APR-22
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-sterile, Powder-Free Latex Examination Glove
Sri Trang Gloves (Thailand) Public510(k) NO: K212309(Abbreviated)
ATTN: Jarinya  Jirojkul           PHONE NO : 66 74 344677 
10 SOi 10 Phetkasem Road          SE DECISION MADE: 08-APR-22
Hatyai  TH 90110                  510(k) STATEMENT
                                                    

DEVICE: Fitbit Irregular Rhythm Notifications
Fitbit Inc                        510(k) NO: K212372(Traditional)
ATTN: Randy  Parry                PHONE NO : 415 9854778 
199 Fremont Street 14th Floor     SE DECISION MADE: 08-APR-22
San Francisco CA  94105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transcutaneous Electrical Applicator (TEA)
Ningbo MedKinetic Medical Device C510(k) NO: K212377(Traditional)
ATTN: Zhang  Wei                  PHONE NO : 86 574 86808886__ 
Lushan West Road 167-8, Ningbo FreSE DECISION MADE: 15-APR-22
Ningbo  CN 315806                 510(k) STATEMENT
                                                    

DEVICE: Intri24 Sheath
Inari Medical, Inc.               510(k) NO: K212392(Traditional)
ATTN: Kit  Cariquitan             PHONE NO : 408 6565985 
9 Parker, Suite 100               SE DECISION MADE: 01-APR-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SONON Ultrasound Imaging System, Model: SONON 500L
Healcerion Co., Ltd               510(k) NO: K212400(Traditional)
ATTN: Sooyeol  Lee                PHONE NO : 82 70 82170820 
1403-ho, 12, Digital-ro 33-gil, GuSE DECISION MADE: 22-APR-22
Seoul  KR 08377                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Isolation Gown
Crown Name Disposable Hygiene Prod510(k) NO: K212422(Traditional)
ATTN: Ying  Fang                  PHONE NO : 86 27 82761940 
Chengbei Industrial Zone,Zhucheng SE DECISION MADE: 29-APR-22
Wuhan  CN 431400                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BONREE Nelaton Catheter
Bonree Medical Co., Ltd           510(k) NO: K212430(Traditional)
ATTN: He  Hongbo                  PHONE NO : 86 760 85207588 
No.4 Longzhu Garden, Wanmu IndustrSE DECISION MADE: 29-APR-22
Zhongshan  CN 528451              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips Incisive CT
Philips Healthcare (Suzhou) Co., L510(k) NO: K212441(Traditional)
ATTN: Shiguang  An                PHONE NO : 86 24 28206367 
No. 258, Zhongyuan Road, Suzhou InSE DECISION MADE: 27-APR-22
Suzhou  CN 215024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack
Geistlich Pharma AG               510(k) NO: K212463(Traditional)
ATTN: Marco  Steiner              PHONE NO : 41 41 4926767 
Bahnhofstrasse 40                 SE DECISION MADE: 05-APR-22
Wolhusen  CH CH-6110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EARP Interbody System
Nvision Biomedical Technologies, I510(k) NO: K212477(Traditional)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4590 Lockhill Selma               SE DECISION MADE: 28-APR-22
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G7® Vivacit-E® Freedom® Constrained Liner
Zimmer, Inc.                      510(k) NO: K212512(Traditional)
ATTN: Romil  Sheth                PHONE NO : 574 2688196 
1800 W. Center Street             SE DECISION MADE: 28-APR-22
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Pen Needle for Single Use, Insulin Pen Needles
Berpu Medical Technology Co., Ltd.510(k) NO: K212514(Traditional)
ATTN: Buxin  Yu                   PHONE NO : 86 577 86651999 
NO.14 Xingji Road,Yongxing Street,SE DECISION MADE: 29-APR-22
Wenzhou  CN 325000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lilliput APD System
Fresenius Medical Care Renal Thera510(k) NO: K212522(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 9969103 
920 Winter Street                 SE DECISION MADE: 15-APR-22
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IVX Fluid Transfer Set
Omnicell, Inc.                    510(k) NO: K212530(Traditional)
ATTN: David  Vanella              PHONE NO : 724 7418115 
500 Cranberry Woods Drive         SE DECISION MADE: 24-APR-22
Cranberry PA  16066               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRPx Locking Distal Radius Plate System
Orthopaedic Implant Company       510(k) NO: K212601(Traditional)
ATTN: Douglas  Fulton             PHONE NO : 775 6368281 
770 Smithridge Dr. #400           SE DECISION MADE: 05-APR-22
Reno NV  89502                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RibFix Blu Thoracic Fixation System
Biomet Microfixation              510(k) NO: K212608(Traditional)
ATTN: Lauren  Jasper              PHONE NO : 904 7414400 
1520 Tradeport Drive              SE DECISION MADE: 22-APR-22
Jacksonville FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune. AI Co., Ltd.        510(k) NO: K212624(Traditional)
ATTN: Chen  Ming-Fong             PHONE NO : 886 4 23226363 
Rm. D, 8F , NO. 573, Sec. 2, TaiwaSE DECISION MADE: 04-APR-22
Taichung  TW 403020               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AliveCor QT Service
AliverCor, Inc.                   510(k) NO: K212662(Traditional)
ATTN: Shani  Frenkel              PHONE NO : 650 4474840 
444 Castro Street, Suite 600      SE DECISION MADE: 26-APR-22
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aboNT SYRINGE
Nipro Medical Corporation         510(k) NO: K212677(Traditional)
ATTN: Jessica  Oswald-McLeod      PHONE NO : 305 4326699 
3150 NW 107th Ave                 SE DECISION MADE: 15-APR-22
Doral FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SteriTite Container System with MediTray Products
Case Medical, Inc.                510(k) NO: K212711(Traditional)
ATTN: Michael  Polozani           PHONE NO : 201 3131999 
50 West Street                    SE DECISION MADE: 29-APR-22
Bloomfield NJ  07003              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Micro Catheter and Guidewire System
Suzhou Hengrui Hongyuan Medical Co510(k) NO: K212719(Traditional)
ATTN: Wang  Peipei                PHONE NO : 86 512 68356665 
Building B9 Unit 201, No. 218 XingSE DECISION MADE: 11-APR-22
Suzhou  CN 215126                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INHANCE™ Reverse Shoulder System
Depuy Ireland UC                  510(k) NO: K212737(Traditional)
ATTN: Yayoi  Fujimaki             PHONE NO : 508 8283541 
Loughbeg                          SE DECISION MADE: 21-APR-22
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARDO Alyssa
ARDO Medical AG                   510(k) NO: K212773(Traditional)
ATTN: Thomas  Schlieper           PHONE NO : 41 41 7547070 
Gewerbestrasse 19                 SE DECISION MADE: 15-APR-22
Unteraegeri  CH 6314              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ti3Z Lumbar Interbody System
Zavation Medical Products, LLC    510(k) NO: K212811(Traditional)
ATTN: Katie  Motley               PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 12-APR-22
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intense Pulsed Light (IPL) System
Shenzhen Fansizhe Science And Tech510(k) NO: K212881(Traditional)
ATTN: Cheng  Endang               PHONE NO : 86 755 85275266 
2nd and 3rd floors, No. 17, Xinfa SE DECISION MADE: 11-APR-22
Shenzhen  CN 518125               510(k) STATEMENT
                                                    

DEVICE: SCOUT BX Delivery System
Merit Medical Systems, Inc.       510(k) NO: K212882(Traditional)
ATTN: Sari  Stevens               PHONE NO : 801 2084674 
1600 W Merit Parkway              SE DECISION MADE: 08-APR-22
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lorals
Brazen Goods Inc. dba Lorals      510(k) NO: K212928(Traditional)
ATTN: Melanie  Cristol            PHONE NO : 1 323 8134220 
106 1/2 Judge John Aiso St. #305  SE DECISION MADE: 22-APR-22
Los Angeles CA  90012             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves
Watchtower PPE Supplies Inc.      510(k) NO: K212929(Traditional)
ATTN: Riva  Zheng                 PHONE NO : 1 646 7176266 
600 W John Street, Ste 140B       SE DECISION MADE: 09-APR-22
Hicksville NY  11801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trinity Plus Wrinkle Reducer
Carol Cole Company dba NuFACE     510(k) NO: K212947(Traditional)
ATTN: David  Reece                PHONE NO : 323 3693355 
1325 Sycamore Ave, Suite A        SE DECISION MADE: 02-APR-22
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
Psychemedics Corporation          510(k) NO: K212952(Traditional)
ATTN: Neil  Stowe                 PHONE NO : 310 2167776 6021
5832 Uplander Way                 SE DECISION MADE: 18-APR-22
Culver City CA  90230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRELLIS™ SI Joint Fusion System
OrthoFundamentals, LLC            510(k) NO: K212962(Traditional)
ATTN: Matthew  Palmer             PHONE NO : 617 3062169 
173 Governors Ave                 SE DECISION MADE: 11-APR-22
Medford MA  02155                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MirrorMe3D Modeling System
MirrorMe3D, LLC                   510(k) NO: K212981(Traditional)
ATTN: Jordan  Mills               PHONE NO : 212 3764546 
222 W 37th St., Suite 1501        SE DECISION MADE: 22-APR-22
New York NY  10018                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer (model: E201)
Bioland Technology Ltd            510(k) NO: K213011(Traditional)
ATTN: Wenjuan  Xia                PHONE NO : 86 755 36900999 
No. A6B7 (Block G) ShangRong IndusSE DECISION MADE: 05-APR-22
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DORA Disposable A.V. Fistula Needle Sets
Bain Medical Equipment (Guangzhou)510(k) NO: K213015(Traditional)
ATTN: Zoe  Zeng                   PHONE NO : 86 20 66856868 
No.10, Juncheng Road, Eastern AreaSE DECISION MADE: 08-APR-22
Guangzhou  CN 510760              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: K213040(Special)
ATTN: Xiaoge  Yu                  PHONE NO : 86 135 70952157 
No. 28 Delong Ave., Shijiao Town, SE DECISION MADE: 27-APR-22
Qingyuan  CN 511545               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TLX SRAs and TLX Gold Abutments
Institut Straumann AG             510(k) NO: K213063(Traditional)
ATTN: Gina  Chang                 PHONE NO : 41 61 9651128 
Peter Merian Weg 12               SE DECISION MADE: 08-APR-22
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatically Retractable Safety Syringe
Zhejiang Lingyang Medical Apparatu510(k) NO: K213077(Traditional)
ATTN: Wang  Minjun                PHONE NO : 86 0576 85800258 
Baishuiyang Town                  SE DECISION MADE: 27-APR-22
Linhai  CN 317031                 510(k) STATEMENT
                                                    

DEVICE: Dakota ALIF System
Precision Spine, Inc.             510(k) NO: K213118(Traditional)
ATTN: Michael  Dawson             PHONE NO : 601 4204244 
2050 Executive Drive.             SE DECISION MADE: 01-APR-22
Pear MS  39208                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Keffort (MC-100, MC-100A)
Oriental Inspiration Limited      510(k) NO: K213133(Traditional)
ATTN: Francis  Ko                 PHONE NO : 852 26873496 
Unit D (01), 14/F.,Block 1,Tai PinSE DECISION MADE: 13-APR-22
Hong Kong  CN                     510(k) STATEMENT
                                                    

DEVICE: CARESCAPE B650, E-musb
GE Healthcare Finland Oy          510(k) NO: K213181(Traditional)
ATTN: Joel  Kent                  PHONE NO : 358 1039411 
Kuortaneenkatu 2                  SE DECISION MADE: 13-APR-22
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
GE Medical Systems Information Tec510(k) NO: K213234(Traditional)
ATTN: Joel  Kent                  PHONE NO : 617 8510943 
9900 Innovation Drive             SE DECISION MADE: 12-APR-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
GenMark Diagnostics, Incorporated 510(k) NO: K213236(Traditional)
ATTN: Alan  Maderazo              PHONE NO : 760 4484308 
5964 La Place Court               SE DECISION MADE: 27-APR-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tomey Cornea/Anterior Segment OCT CASIA2
Tomey Corporation                 510(k) NO: K213265(Traditional)
ATTN: Yuko  Matsushita            PHONE NO : 81 525 815327 
2-11-33 Noritakeshinmachi         SE DECISION MADE: 27-APR-22
Nishi-ku  JP 451-0051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Planmed Verity
Planmed Oy                        510(k) NO: K213278(Traditional)
ATTN: Niina  Vuorikallas          PHONE NO : 358 20 7795300 
Sorvaajankatu 7                   SE DECISION MADE: 28-APR-22
Helsinki  FI 00880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ERI Handheld Dental X-ray System (Model AG100)
Energy Resources International Co.510(k) NO: K213282(Traditional)
ATTN: Nancy  Liu                  PHONE NO : 886 3 6585156 
2F-2, No. 6-1, Sec. 2, Zhengyi Rd SE DECISION MADE: 04-APR-22
Zhubei City  TW 30261             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anprolene SteriTest RRBI
Andersen Sterilizers, Inc.        510(k) NO: K213296(Traditional)
ATTN: William K Andersen          PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 12-APR-22
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monarch Platform, Urology
Auris Health Inc                  510(k) NO: K213334(Traditional)
ATTN: Angela  Wong                PHONE NO : 408 6139734 
150 Shoreline Drive               SE DECISION MADE: 29-APR-22
Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carescape B850, E-musb
GE Healthcare Finland OY          510(k) NO: K213336(Traditional)
ATTN: Joel  Kent                  PHONE NO : 35 810 39411 
Kuortaneenkatu 2                  SE DECISION MADE: 13-APR-22
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: mJOULE System and Accessories
Sciton, Inc                       510(k) NO: K213350(Traditional)
ATTN: Jay  Patel                  PHONE NO : 650 5438348 
925 Commercial Street             SE DECISION MADE: 15-APR-22
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARESCAPE B450, E-musb
GE Healthcare Finland Oy          510(k) NO: K213363(Traditional)
ATTN: Joel  Kent                  PHONE NO : 358 10 39411 
Kuortaneenkatu 2                  SE DECISION MADE: 13-APR-22
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
AngioDynamics, Inc.               510(k) NO: K213388(Traditional)
ATTN: Kasey E. Newcomb            PHONE NO : 508 6587813 
603 Queensbury Ave                SE DECISION MADE: 04-APR-22
Queensbury NY  12804              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMBOLD Fibered Detachable Coil System
Boston Scientific Corporation     510(k) NO: K213398(Traditional)
ATTN: Heidi  Shearer              PHONE NO : 763 2550056 
One Scimed Place                  SE DECISION MADE: 12-APR-22
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
Meditech Gloves SDN BHD           510(k) NO: K213408(Traditional)
ATTN: Effendi  Tenang             PHONE NO : 606 799 7742 
PT 3345, Jalan Permata 1/3, Arab MSE DECISION MADE: 17-APR-22
Nilai  MY 71800                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS Angulated multi-unit abutments
Dentsply Sirona                   510(k) NO: K213432(Traditional)
ATTN: Courtney  Clark             PHONE NO : 248 8954379 
221 West Philadelphia Street, SuitSE DECISION MADE: 01-APR-22
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
Central Medicare Sdn Bhd          510(k) NO: K213437(Traditional)
ATTN: Fatin Nor Irdina Bt Ahmad FaPHONE NO : 60 562 90000 
PT 2609-2620, Batu 8, Jalan ChangkSE DECISION MADE: 11-APR-22
Teluk Intan  MY 36000             510(k) STATEMENT
                                                    

DEVICE: Medical surgical mask (Black mask, Level 1 and Level 3)
Guangdong Kingfa Sci.&Tech. Co., L510(k) NO: K213450(Traditional)
ATTN: Yu  Xiaoge                  PHONE NO : 86 2632 8999 
28 Delong Avenue, Shijiao Town, QiSE DECISION MADE: 05-APR-22
Qingyuan City  CN 511500          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEMS-H
Samsung Electronics Co., Ltd.     510(k) NO: K213452(Traditional)
ATTN: Minhyung  Lee               PHONE NO : 82 2 61473805 
129, Samsung-Ro, Yeongtong-Gu     SE DECISION MADE: 21-APR-22
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TIA Tip, Cariosity, Transillumination Accessory Tip
D4D Technologies, LLC             510(k) NO: K213482(Traditional)
ATTN: Eddie  Anderson             PHONE NO : 972 5343101 721
2920 Telecom Parkway, Suite 100   SE DECISION MADE: 29-APR-22
Richardson TX  75082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SnapLoc Wire Lock
Wilson Cook Medical               510(k) NO: K213483(Traditional)
ATTN: Paul  Meyer                 PHONE NO : 812 7191665 
4900 Bethania Station Road        SE DECISION MADE: 26-APR-22
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmoothCool HR System
Jeisys Medical Inc                510(k) NO: K213484(Special)
ATTN: Sang Hoon Hwang             PHONE NO : 
307, 308, 401, Daeryung Techno TowSE DECISION MADE: 20-APR-22
Seoul  KR 08501                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
GE Medical Systems Information Tec510(k) NO: K213490(Traditional)
ATTN: Joel  Kent                  PHONE NO : 617 8510943 
9900 Innovation Drive             SE DECISION MADE: 01-APR-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aveir Retrieval Catheter
Abbott Medical                    510(k) NO: K213494(Traditional)
ATTN: Bijal  Jain                 PHONE NO : 1 818 2825438 
15900 Valley View Court           SE DECISION MADE: 01-APR-22
Sylmar CA  91342                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NB 1 SA Implant System
Arumdentistry Co., Ltd.           510(k) NO: K213506(Traditional)
ATTN: Hyang Mi Lee                PHONE NO : 82 42 9353644 
1-dong, 44, Techno 8-ro, Yuseong-gSE DECISION MADE: 06-APR-22
Daejeon  KR 34028                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Latex Examination Gloves, Powder Free
Shandong Intco Medical Products Co510(k) NO: K213509(Traditional)
ATTN: Haisheng  Yu                PHONE NO : 
9888 Qiwang Road, Naoshan IndustriSE DECISION MADE: 08-APR-22
Qingzhou  CN 2625000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARESCAPE CO2 Microstream parameter
Covidien llc                      510(k) NO: K213518(Traditional)
ATTN: Inna  Reznikov              PHONE NO : 303 5791718 
6135 Gunbarrel Ave                SE DECISION MADE: 12-APR-22
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PuraStat-RM
3-D Matrix, Inc.                  510(k) NO: K213552(Traditional)
ATTN: Lisa  Spirio                PHONE NO : 617 8756204 
1234 Chestnut St., Suite 205      SE DECISION MADE: 01-APR-22
Newton MA  02464                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finexel
SNJ Co., Ltd                      510(k) NO: K213557(Traditional)
ATTN: Taehi  Chang                PHONE NO : 82 2 8669005 
#604, Ace-Techno Tower 2, Digital SE DECISION MADE: 12-APR-22
Seoul  KR                         510(k) STATEMENT
                                                    

DEVICE: FEMTO LDV Z8 Femtosecond Surgical Laser
SIE AG, Surgical Instrument Engine510(k) NO: K213559(Traditional)
ATTN: Frank  Ziemer               PHONE NO : 41 32 3327070 
Allmendstrasse 11                 SE DECISION MADE: 21-APR-22
Port  CH CH-2502                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Verifine Safety Syringe with Fixed Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K213560(Traditional)
ATTN: Zearou  Yang                PHONE NO : 86 571 88772985 
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 05-APR-22
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Balloon Dilatation Catheter
Hangzhou AGS MedTech Co., Ltd.    510(k) NO: K213578(Traditional)
ATTN: Jiayuan  Zhang              PHONE NO : 86 571 87671223 
Building 5, Building 6, No.597 KanSE DECISION MADE: 06-APR-22
Hangzhou  CN 311106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELAZ Nitrile Powder Free Examination Glove
Protect Gloves Co., Ltd.          510(k) NO: K213604(Traditional)
ATTN: Nathaphon  Wachakorn        PHONE NO : 66 2 3843049 
60/138 Moo 3 Mabyangporn          SE DECISION MADE: 03-APR-22
Pluakdang  TH 21140               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geistlich Wound Matrix PLUS
Geistlich Pharma AG               510(k) NO: K213607(Traditional)
ATTN: Erik  Wirth                 PHONE NO : 41 41 4926764 
Bahnhofstrasse 40                 SE DECISION MADE: 28-APR-22
Wolhusen  CH 6110                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATUSA™ Automated 3D Breast Ultrasound System
iSono Health, Inc.                510(k) NO: K213620(Traditional)
ATTN: Shadi  Saberi               PHONE NO : 415 8573073 
395 Oyster Point Blvd., Suite 501 SE DECISION MADE: 22-APR-22
South San Fransisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
Ethicon Endo-Surgery, LLC         510(k) NO: K213633(Traditional)
ATTN: Nathan  Anderson            PHONE NO : 787 2726144 
475 Calle C                       SE DECISION MADE: 08-APR-22
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BodyTom 64
NeuroLogica Corporation,          510(k) NO: K213649(Traditional)
ATTN: Ninad  Gujar                PHONE NO : 978 5648632 
a subsidiary of Samsung ElectronicSE DECISION MADE: 29-APR-22
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermPix Thermovisual Camera
USA Therm, Inc.                   510(k) NO: K213650(Traditional)
ATTN: Ariel  Soffer               PHONE NO : 1 844 9984376 
21550 Biscayne Boulevard, Suite 13SE DECISION MADE: 12-APR-22
Aventura FL  33180                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEEPVESSEL FFR
KeyaMed NA Inc.                   510(k) NO: K213657(Traditional)
ATTN: Xiaoxiao  Liu               PHONE NO : 206 5081036 
107 Spring Street                 SE DECISION MADE: 01-APR-22
Seattle WA  98104                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MP Reconstruction System
Waldemar Link GmbH & Co.KG        510(k) NO: K213675(Special)
ATTN: Lydia  Ditter               PHONE NO : 49 40 53575573 
Oststrabe 4-10                    SE DECISION MADE: 11-APR-22
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ivory Glove Powder-Free Nitrile Examination Gloves
Ivory Gloves SDN. BHD.            510(k) NO: K213681(Traditional)
ATTN: Arasi  No Last Name ProvidedPHONE NO : 6014 6030730 
Lot 7806 Jalan Perusahaan 1,  KawaSE DECISION MADE: 21-APR-22
Kamunting  MY 34600               510(k) STATEMENT
                                                    

DEVICE: Promisemed Fine Biopsy Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K213683(Traditional)
ATTN: Zearou  Yang                PHONE NO : 86 571 88772985 
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 22-APR-22
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI-Rad Companion Brain MR
Siemens Healthcare GmBh           510(k) NO: K213706(Traditional)
ATTN: Kira  Kuzmenchuk            PHONE NO : 484 9019471 
40 Liberty Blvd. Mail Code 65-1   SE DECISION MADE: 15-APR-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA® Knee System
Orthosoft, Inc (d/b/a Zimmer CAS) 510(k) NO: K213708(Traditional)
ATTN: Paul  Hardy                 PHONE NO : 574 4536739 
75 Queen St, Suite 3300           SE DECISION MADE: 22-APR-22
Montreal  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
Mesi, Development of Medical Devic510(k) NO: K213730(Traditional)
ATTN: Jakob  Susteric             PHONE NO : 386 1 6203487 
Leskoskova cesta 11A              SE DECISION MADE: 21-APR-22
Ljubljana  SI 1000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital thermometer, Model DT101, DT102
Guangzhou Berrcom Medical Device C510(k) NO: K213746(Traditional)
ATTN: Zhigang  Du                 PHONE NO : 86 020 34938449 
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 05-APR-22
Guangzhou  CN 511470              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glovatex™ White Latex Gloves, Glovanil™  Blue Nitrile Gloves
Avecena Gloves Sdn Bhd            510(k) NO: K213775(Traditional)
ATTN: Mohd Aswad bin Ramli        PHONE NO : 60 193477659 
Lot 50592 Sendayan Techvalley BandSE DECISION MADE: 24-APR-22
Negeri Sembilan  MY 71950         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apyx
Escala Medical                    510(k) NO: K213783(Traditional)
ATTN: Edit  Goldberg              PHONE NO : 972 72 2607000 
17th Tchelet Street               SE DECISION MADE: 05-APR-22
Misgav Industrial Park  IL 2017400510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMPOWR Revision Knee
Encore Medical, L.P.              510(k) NO: K213793(Traditional)
ATTN: Michael  Siano              PHONE NO : 512 7914219 
9800 Metric Blvd.                 SE DECISION MADE: 01-APR-22
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Videa Caries Assist
VideaHealth, Inc                  510(k) NO: K213795(Traditional)
ATTN: Florian  Hill               PHONE NO : 1 617 5288643 
19 Kingston St                    SE DECISION MADE: 21-APR-22
Bostong MA  02111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
Co-Innovation Biotech Co.,Ltd.    510(k) NO: K213808(Special)
ATTN: Hong  Feng                  PHONE NO : 86 20 62867285 
No. 9 Baihe 3 Street, Economic AndSE DECISION MADE: 05-APR-22
Guangzhou  CN 510507              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest  Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader
3M Company                        510(k) NO: K213809(Traditional)
ATTN: Hilary  Hovde               PHONE NO : 651 7360364 
3M Center 2510 Conway Ave, BuildinSE DECISION MADE: 06-APR-22
Saint Paul MN  55144              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CER-S
CardioCalm Srl                    510(k) NO: K213861(Traditional)
ATTN: Fabio  Badilini             PHONE NO : 39 030 9650782 
Via Martiri della Liberta, nr. 40 SE DECISION MADE: 25-APR-22
Montichiari  IT 25018             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BriefCase
Aidoc Medical, Ltd.               510(k) NO: K213886(Traditional)
ATTN: Nimrod  Epstein             PHONE NO : 972 73 7946870 
3 Aminaday St.                    SE DECISION MADE: 26-APR-22
Tel-Aviv  IL 6706703              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoStar
Asclepion Laser Technologies GmbH 510(k) NO: K213889(Traditional)
ATTN: Carolin  Kuehling           PHONE NO : 49 3641 7700213 
Bruesseler Strasse 10             SE DECISION MADE: 22-APR-22
Jena  DE 07747                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microthin Natural Rubber Latex Condom
Suretex Limited                   510(k) NO: K213921(Abbreviated)
ATTN: KC  Nguyen                  PHONE NO : 66 77 277400 
31/1 Moo 4, Suratthani-Thakuapha RSE DECISION MADE: 28-APR-22
Tambon Khao Hua Kwai, Amphur Phunp510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyoCycle MC-2 (Home / Home + / Pro / Pro +)
Myolyn, LLC                       510(k) NO: K213925(Traditional)
ATTN: Matthew  Bellman            PHONE NO : 352 2049066 101
6931 NW 22nd Street, Suite A      SE DECISION MADE: 25-APR-22
Gainesville FL  32653-1231        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brainlab Elements Guide XT, Guide 3.0
Brainlab AG                       510(k) NO: K213930(Traditional)
ATTN: Chiara  Cunico              PHONE NO : 49 899 915681738 
Olof-Palme-Str.9                  SE DECISION MADE: 19-APR-22
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HealthOST
NanoxAI Ltd.                      510(k) NO: K213944(Traditional)
ATTN: Shlomit  Cymbalista         PHONE NO : 972 52 2574837 
Shefayim Commercial Center, PO BoxSE DECISION MADE: 22-APR-22
Shefayim  IL 6099000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bioabsorbable Anchor
Embody, Inc.                      510(k) NO: K213958(Traditional)
ATTN: Brianna  Schehr             PHONE NO : 236 9947912 
4211 Monarch Way, Suite 500       SE DECISION MADE: 08-APR-22
Norfolk VA  23508                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagnetOs Flex Matrix
Kuros Biosciences BV              510(k) NO: K213959(Traditional)
ATTN: Sonja  van der Meer         PHONE NO : 31 302297280 
Professor Bronkhorstlaan 10, buildSE DECISION MADE: 14-APR-22
Bilthoven  NL 3723 MB             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEM FLOW COUPLER Monitor (GEM1020M-2)
Synovis Micro Companies Alliance, 510(k) NO: K213974(Special)
ATTN: Russell  Pagano             PHONE NO : 224 2463367 
(a Subsidiary of Baxter InternatioSE DECISION MADE: 20-APR-22
Birmingham AL  35211              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invictus® Spinal Fixation System
Alphatec Spine, Inc.              510(k) NO: K214006(Traditional)
ATTN: Sandy  Gill                 PHONE NO : 760 4946633 
1950 Camino Vida Roble            SE DECISION MADE: 04-APR-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anteralign Spinal System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA       510(k) NO: K214010(Traditional)
ATTN: Elizabeth  Hamilton         PHONE NO : 901 3993395 
1800 Pyramid Place                SE DECISION MADE: 12-APR-22
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
bioMerieux, Inc                   510(k) NO: K214023(Traditional)
ATTN: Kyle J Olney                PHONE NO : 314 7318666 
595 Anglum Rd.                    SE DECISION MADE: 14-APR-22
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
Medos International Sarl          510(k) NO: K214025(Special)
ATTN: Ivenette  Guzman            PHONE NO : 954 4157177 
Chemin-Blanc 38                   SE DECISION MADE: 12-APR-22
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPoint Array System (version 1.1)
ClearPoint Neuro, Inc.            510(k) NO: K214040(Traditional)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 12-APR-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FreedomEdge Syringe Infusion System
Repro-Medical System, Inc., dba Ko510(k) NO: K214045(Traditional)
ATTN: Christopher  Pazdan         PHONE NO : 845 6105587 
24 Carpenter Road                 SE DECISION MADE: 29-APR-22
Chester NY  10918                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System-Helix NGM Compact Surgical Kit Cases
JJGC Indústria e Comércio de Mater510(k) NO: K214051(Traditional)
ATTN: Thais  Barboza              PHONE NO : 55 41 21694000 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 13-APR-22
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amputee Garment for use with Lympha Press Optimal Plus
Mego Afek AC Ltd.                 510(k) NO: K214053(Traditional)
ATTN: Ilan  Sharon                PHONE NO : 972 528 704904 
Kibbuts Afek                      SE DECISION MADE: 14-APR-22
Kibbuts Afek  IL 3004200          510(k) STATEMENT
                                                    

DEVICE: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K214075(Traditional)
ATTN: Bingyi  Xiang               PHONE NO : 86 556 5129666 
No.2 Guanyin Road Economic DevelopSE DECISION MADE: 12-APR-22
Anqing  CN 246400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRCAT Head & Neck
Philips Oy                        510(k) NO: K214081(Traditional)
ATTN: Janne  Marvola              PHONE NO : 358 40 1261214 
Ayritie 4                         SE DECISION MADE: 05-APR-22
Vantaa  FI 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Mask
Hubei Wanli Protective Products Co510(k) NO: K214085(Traditional)
ATTN: Andy  Wen                   PHONE NO : 86 728 3227299 
Yuanshi, Ganhe                    SE DECISION MADE: 06-APR-22
Xiantao  CN 433000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Gown
Weihai Hongyu Nonwoven Fabric Prod510(k) NO: K214088(Traditional)
ATTN: Bin  Dong                   PHONE NO : 86 0631 3636942 
No.567, Gushan Road, Area of EconoSE DECISION MADE: 12-APR-22
Weihai  CN 264207                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XO CROSS CORONARY Support Catheter
Transit Scientific, LLC           510(k) NO: K214107(Traditional)
ATTN: Jennifer  Arnold            PHONE NO : 412 4963609 
2757 South 300 West, Suite E      SE DECISION MADE: 11-APR-22
Salt Lake City UT  84115          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prodigy Thrombectomy System
Truvic Medical Inc.               510(k) NO: K214114(Traditional)
ATTN: Micheal  Buck               PHONE NO : 650 8420240 
1359 Dell Ave                     SE DECISION MADE: 06-APR-22
Campbell CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS & PMS Unit
Shenzhen Yuehua Xinsen Technology 510(k) NO: K220005(Traditional)
ATTN: Evin  Li                    PHONE NO : 86 153 02652776 
No. 27-201, Zhongwu 3rd Road, ZhonSE DECISION MADE: 01-APR-22
Shenzhen  CN 518128               510(k) STATEMENT
                                                    

DEVICE: TRATE Dental Implant System
Trate AG                          510(k) NO: K220022(Traditional)
ATTN: Vladlena  Shulezhko         PHONE NO : 41 44 2021919 
Seestrasse 58                     SE DECISION MADE: 04-APR-22
Bäch  CH H-8806                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Audion ET dilation system
Entellus Medical, Inc.            510(k) NO: K220027(Traditional)
ATTN: Katie  Wilson               PHONE NO : 1 269 8880315 
3600 Holly Lane North, Suite 40   SE DECISION MADE: 12-APR-22
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Camber Spine Navigation System
Camber Spine Technologies         510(k) NO: K220038(Traditional)
ATTN: Noel  Hetrick               PHONE NO : 484 4277060 
501 Allendale Rd                  SE DECISION MADE: 29-APR-22
King of Prussia PA  19406         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., LTD          510(k) NO: K220043(Traditional)
ATTN: Jee Young Ju                PHONE NO : 82 221 940861 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 05-APR-22
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Nitrile Examination Gloves
Hunan Zhenheyikang Medical Instrum510(k) NO: K220066(Traditional)
ATTN: Yilin  Yin                  PHONE NO : 86 0731 58262222 
No.6 Building Jingxiang Energy,No.SE DECISION MADE: 03-APR-22
Xiangtan  CN 411100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spartan Center Wire
Spartan Micro, Inc.               510(k) NO: K220075(Traditional)
ATTN: Gary  Avedovech             PHONE NO : 512 2708501 
3184 Airway Ave, Suite C          SE DECISION MADE: 19-APR-22
Costa Mesa CA  92626              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LED Therapy Device (Planar LED/Planar LED mini)
Shenzhen Leaflife Technology Co., 510(k) NO: K220103(Traditional)
ATTN: Cheng  Qiang                PHONE NO : 086 01 7875910506 
4F,Bldg. C, JMD Industrial Park, NSE DECISION MADE: 12-APR-22
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
AAMedix Glove Sdn Bhd             510(k) NO: K220121(Traditional)
ATTN: Annette  Schaps             PHONE NO : 510 366 6241 
Unit 19D, Level 19, No.16, PersiarSE DECISION MADE: 11-APR-22
Selanger Darul Ehsan  MY 40170    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KYPHON VuE Bone Cement
Tecres S.p.A.                     510(k) NO: K220131(Traditional)
ATTN: Massio  Grazioli            PHONE NO : 39 045 9217311 
via Andrea Doria 6                SE DECISION MADE: 18-APR-22
Sommacampagna  IT 37066           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RayStation 11B
RaySearch Laboratories AB (publ)  510(k) NO: K220141(Traditional)
ATTN: David  Hedfors              PHONE NO : 46 8510 53000 
Eugeniavägen 18                   SE DECISION MADE: 15-APR-22
Stockholm  SE 113 68              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
NORAS MRI Products GmbH           510(k) NO: K220144(Traditional)
ATTN: Manuel  Noras               PHONE NO : 49 931 299270 
Leibnizstrasse 4                  SE DECISION MADE: 08-APR-22
Hoechberg  DE 97204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)
XERA Medical Systems & Technology 510(k) NO: K220149(Traditional)
ATTN: Zeynep  Oruc                PHONE NO : 90 544 7300406 
Gulden sok. No: 13/2              SE DECISION MADE: 19-APR-22
Ankara  TR 06690                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Avanto Fit
Siemens Medical Solutions USA, Inc510(k) NO: K220151(Traditional)
ATTN: Karthik  Pillai             PHONE NO : 317 3718593 
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 01-APR-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
Hong Qiangxing (Shen Zhen) Electro510(k) NO: K220152(Traditional)
ATTN: Xu  jianhua                 PHONE NO : 86 755 26423665 
4F, Jingcheng Building, Xicheng InSE DECISION MADE: 19-APR-22
Shenzhen  CN 518126               510(k) STATEMENT
                                                    

DEVICE: G-EYE System
Smart Medical Systems Ltd.        510(k) NO: K220158(Traditional)
ATTN: Adva  Yoselzon              PHONE NO : 972 9 7444321 
5 HaNofar St.                     SE DECISION MADE: 11-APR-22
Ra'anana  IL 4366404              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GM85
Samsung Electronics Co. Ltd.      510(k) NO: K220175(Traditional)
ATTN: Jaesang  Noh                PHONE NO : 82 2 21932444 
129, Samsung-Ro, Yeongtong-Gu     SE DECISION MADE: 21-APR-22
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LISA Laser Surgical Fibers
Omni-Guide Holdings, Inc.         510(k) NO: K220189(Traditional)
ATTN: Carlos O Acosta             PHONE NO : 617 5514400 563
46 Manning Road                   SE DECISION MADE: 29-APR-22
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K220192(Traditional)
ATTN: Paul  Biggins               PHONE NO : 951 3137400 
1385 Shimoishigami                SE DECISION MADE: 08-APR-22
Otawara-Shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Glove, Non-sterile (Blue)
KSG MEDICARE Sdn. Bhd.            510(k) NO: K220209(Traditional)
ATTN: Jennifer  Yeo               PHONE NO : 60 377 331388 
PTD 16063, Kawasan Perindustrian  SE DECISION MADE: 11-APR-22
Tangkak  MY 84900                 510(k) STATEMENT
                                                    

DEVICE: PERMALOOP Suture, PERMATAPE Suture
Medos International SARL          510(k) NO: K220219(Traditional)
ATTN: Ashley  Aromando (Goncalo)  PHONE NO : 508 9773907 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 26-APR-22
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal Device,  model(s): S1-A, S2-A, S1, S2, S3, S4
Shenzhen Yuwei Electronic Technolo510(k) NO: K220222(Traditional)
ATTN: Liu  Xuemeng                PHONE NO : 86 186 76345905 
409, Building 3, 1970 Science ParkSE DECISION MADE: 26-APR-22
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GyroStim
UltraThera Technologies, Inc.     510(k) NO: K220231(Traditional)
ATTN: Kevin  Maher                PHONE NO : 719 6857883 
2 North Cascade Avenue, Suite 640 SE DECISION MADE: 27-APR-22
Colorado Springs CO  80903        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DVR® Crosslock Wrist Spanning Plate (131849181)
Pioneer Surgical Technology, Inc D510(k) NO: K220244(Traditional)
ATTN: Jaclyn  Holli               PHONE NO : 906 2269909 
375 River Park Circle             SE DECISION MADE: 28-APR-22
Marquette MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: High Retention Attachment System
Zest Anchors, LLC                 510(k) NO: K220252(Special)
ATTN: Richard  Hines              PHONE NO : 1 442 2444835 
2875 Loker East                   SE DECISION MADE: 14-APR-22
Carlsbad CA  92026                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EFAI RTSuite CT HN-Segmentation System
Ever Fortune.AI Co., Ltd.         510(k) NO: K220264(Traditional)
ATTN: Joseph  Chang               PHONE NO : 886 04 23226363 
Rm. D, 8F. No. 573, Sec. 2 Taiwan SE DECISION MADE: 28-APR-22
Taichung City  TW 403020          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hand Diagnostic Radiography Imaging System
NanoRay Biotech Co., Ltd          510(k) NO: K220271(Traditional)
ATTN: Alice  Chen                 PHONE NO : 886 2 27968909 
7F., No.91, Xinhu 1st Rd., Neihu DSE DECISION MADE: 29-APR-22
Taipei City  TW 114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invisalign System
Align Technology, Inc.            510(k) NO: K220287(Special)
ATTN: Shweta  Daga                PHONE NO : 408 2032364 
2820 Orchard Parkway              SE DECISION MADE: 07-APR-22
San Jose CA  95134                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIETTA 50
FUJIFILM Healthcare Corporation   510(k) NO: K220295(Abbreviated)
ATTN: Randy  Vader                PHONE NO : 360 356 6821 
2-1, Shintoyofuta                 SE DECISION MADE: 29-APR-22
Kashiwa-Shi  JP 277-0804          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: K220335(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 05-APR-22
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExacTrac Dynamic
Brainlab AG                       510(k) NO: K220338(Traditional)
ATTN: Sadwini  Suresh             PHONE NO : 
Olof-Palme-Str. 9                 SE DECISION MADE: 29-APR-22
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves
NB Medical Co., LTD               510(k) NO: K220343(Traditional)
ATTN: Kecheng  Zhou               PHONE NO : 86 136 15395959 
Tay An Industrial Cluster, Tien HaSE DECISION MADE: 02-APR-22
Thai Binh Province  VN 410000     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accu-Chek Safe-T-Pro Uno Lancing Device
Roche Diabetes Care, Inc.         510(k) NO: K220364(Traditional)
ATTN: Julia  Best                 PHONE NO : 49 173 3198175 
9115 Hague Road                   SE DECISION MADE: 05-APR-22
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
Summit Glove, Inc                 510(k) NO: K220373(Traditional)
ATTN: James  Hull                 PHONE NO : 1 330 8680066___ 
310 South Grant Street            SE DECISION MADE: 13-APR-22
Minerva OH  44657                 510(k) STATEMENT
                                                    

DEVICE: Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
Summit Glove, Inc                 510(k) NO: K220375(Traditional)
ATTN: James  Hull                 PHONE NO : 1 330 8680066 
310 South Grant Street            SE DECISION MADE: 13-APR-22
Minerva OH  44657                 510(k) STATEMENT
                                                    

DEVICE: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple
Jiangsu Bytech Medical Supplies Co510(k) NO: K220382(Traditional)
ATTN: Shen  Hongxing              PHONE NO : 86 510 85093588 
NO.88 Junshi Road, Petroleum EquipSE DECISION MADE: 21-APR-22
Yancheng City  CN 224700          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
Okami Medical                     510(k) NO: K220383(Traditional)
ATTN: Jill  Delsman               PHONE NO : 949 3706314 
8 Argonut Suite 100               SE DECISION MADE: 29-APR-22
Aliso Viejo CA  92656             510(k) STATEMENT
                                                    

DEVICE: Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
Riverstone Resources Sdn Bhd      510(k) NO: K220401(Traditional)
ATTN: Suresh  Kumar               PHONE NO : 605 89 12777 
Lot 20852, No.119, Jalan Logam 7 KSE DECISION MADE: 09-APR-22
Taiping  MY 34600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amis K Long
Medacta International S .A.       510(k) NO: K220405(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 12-APR-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Healthcare Corporation     510(k) NO: K220417(Traditional)
ATTN: Jennifer  Hoogheem          PHONE NO : 224 2702693 
25212 W. Illinois Route 120       SE DECISION MADE: 29-APR-22
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mako Total Knee Application
Mako Surgical Corp.               510(k) NO: K220459(Traditional)
ATTN: Emily  DiMambro             PHONE NO : 201 8315140 
3365 Enterprise Ave.              SE DECISION MADE: 15-APR-22
Weston FL  33331                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellvizio 100 series system with confocal Miniprobes
Mauna Kea Technologies            510(k) NO: K220477(Traditional)
ATTN: Aline  Criton               PHONE NO : 33 170 080994 
9 Rue d'Enghien                   SE DECISION MADE: 11-APR-22
Paris  FR 75010                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Face Mask
Hubei Mediunion Medical Products C510(k) NO: K220487(Traditional)
ATTN: Jason  Sheen                PHONE NO : 0086 574 27882323 
No.1 ChuangYe Road, Zhongling InduSE DECISION MADE: 26-APR-22
Xiantao  CN 433000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImaCor Zura Handheld ZHH-010
ImaCor Inc                        510(k) NO: K220490(Third Party - Traditional)
ATTN: Richard  Lanzillotto        PHONE NO : 631 2557183 
50 Jericho Turnpike Suite 105     SE DECISION MADE: 08-APR-22
Jericho NY  11753                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TENS device-EmeTerm 2, Model: YF-ZTY-E2
WAT Medical Technology Inc.       510(k) NO: K220503(Traditional)
ATTN: Joe  Xu                     PHONE NO : 86 151 62682168 
Room703-711, No.2 North Taoyuan RoSE DECISION MADE: 23-APR-22
Ningbo  CN 315600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yushan X-Ray Flat Panel Detector with DROC
InnoCare Optoelectronics Corp.    510(k) NO: K220510(Traditional)
ATTN: Yumei  Cheng                PHONE NO : 886 6 7007238 22598
Rm. B, No. 2, Sec. 2, Huanxi Rd., SE DECISION MADE: 14-APR-22
Tainan City  TW 741               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Face Mask (M01, M02)
Fomed Industries Inc.             510(k) NO: K220512(Traditional)
ATTN: He  Xing                    PHONE NO : 86 138 69469536 
20 Han Sha Road, Houhu District, QSE DECISION MADE: 25-APR-22
Qianjiang  CN 433115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKANRAD 400
Skanray Technologies Limited      510(k) NO: K220518(Traditional)
ATTN: Vasundhara  R               PHONE NO : 91 821 2415559 
Plot# 15-17, Hebbal Industrial AreSE DECISION MADE: 01-APR-22
Mysore  IN 570016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital flat panel detector
iRay Technology Taicang Ltd.      510(k) NO: K220536(Traditional)
ATTN: Guo  Wu                     PHONE NO : 86 0512 53690872 
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 28-APR-22
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Auxo A300, A150 and APod
Auxo Hair, LLC                    510(k) NO: K220543(Traditional)
ATTN: Patricia  Schnoor           PHONE NO : 305 2553208 
16300 SW 101 Ave                  SE DECISION MADE: 20-APR-22
Miami FL  33157                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OpenSensorX Series
DentiMax, Inc                     510(k) NO: K220556(Special)
ATTN: David  Arnett               PHONE NO : 480 3961798 
4115 E Valley Auto Dr, Suite 101  SE DECISION MADE: 13-APR-22
Mesa AZ  85298                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Examination Gloves
Nanjing universal medical equipmen510(k) NO: K220561(Traditional)
ATTN: Jerry  Gao                  PHONE NO : 86 133 82802871 
288 Qinhuai Avenue, Yongyang StreeSE DECISION MADE: 14-APR-22
Nanjing  CN 210000                510(k) STATEMENT
                                                    

DEVICE: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Cardiovascualr Systems Inc.       510(k) NO: K220568(Traditional)
ATTN: Kris  Miller                PHONE NO : 612 9993749 
1225 Old Highway 8 NW             SE DECISION MADE: 27-APR-22
New Brighton MN  55112            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. MINI Posterior Cervical Screws System Extension
Medacta International S.A.        510(k) NO: K220570(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 26-APR-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYBRID S70
Digimed Co., LTD.                 510(k) NO: K220574(Traditional)
ATTN: Youngbae  Kwon              PHONE NO : 
145, Gasan digital 1-ro, GeumcheonSE DECISION MADE: 22-APR-22
Seoul  KR 08506                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avanos* CORTRAK* 2 Enteral Access System (EAS)
Avanos Medical Inc                510(k) NO: K220588(Traditional)
ATTN: Nikin  Desai                PHONE NO : 1 732 6682384 
5405 Windward Parkway             SE DECISION MADE: 22-APR-22
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aPROMISE X
EXINI Diagnostics AB              510(k) NO: K220590(Traditional)
ATTN: Aseem  Anand                PHONE NO : 46 706 604084 
Ideon Science Park, Scheelevagen 2SE DECISION MADE: 29-APR-22
Lund  SE SE-223 70                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus BlissMAX
Venus Concept USA Inc.            510(k) NO: K220592(Traditional)
ATTN: William H. McGrail          PHONE NO : 978 8080420 
1880 N Commerce Pkwy, Suite 2     SE DECISION MADE: 27-APR-22
Weston FL  33326                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoolTone
Zimmer MedizinSysteme GmbH        510(k) NO: K220601(Special)
ATTN: Julia  Kredler              PHONE NO : 49 731 9761625 
Junkersstrasse 9                  SE DECISION MADE: 01-APR-22
Neu-Ulm  DE 89231                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXTesia Introducer Sheath Set
Curatia Medical Co.               510(k) NO: K220604(Traditional)
ATTN: Jessica  Chiu               PHONE NO : 408 7738839 
830 Stewart Dr.                   SE DECISION MADE: 27-APR-22
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus Bulk Flow ONE
Kulzer, LLC                       510(k) NO: K220605(Special)
ATTN: Marc  Henn                  PHONE NO : 574 2995444 
4315 S. Lafayette Blvd            SE DECISION MADE: 21-APR-22
South Bend IN  46614              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accu-Chek FastClix Blood Lancing System
Roche Diabetes Care, Inc          510(k) NO: K220608(Traditional)
ATTN: Thomas  Kristen             PHONE NO : 49 15254 791230 
9115 Hague Road                   SE DECISION MADE: 29-APR-22
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
REMED Co., Ltd                    510(k) NO: K220625(Special)
ATTN: Yuna  Cho                   PHONE NO : 82 10 90269256 
#301-#303 Migun Techno World II, 1SE DECISION MADE: 06-APR-22
Daejeon  KR 34025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hand-held IPL device (JOVS Hair Removal Device)
Shenzhen Qianyu Technology Co., Lt510(k) NO: K220645(Traditional)
ATTN: Kunming  Lin                PHONE NO : 86 158 13806593 
Room 1002, Building A2, KeXing SciSE DECISION MADE: 27-APR-22
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
Cordis Corporation                510(k) NO: K220654(Special)
ATTN: Dunia  Bram                 PHONE NO : 52 656 1707001 04524
14201 N.W. 60th Avenue            SE DECISION MADE: 06-APR-22
Miami Lakes FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd.      510(k) NO: K220668(Special)
ATTN: Junjie  Qian                PHONE NO : 86 0512 53690872 
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 01-APR-22
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oryx Cloud Imaging
Oryx Dental Software INC          510(k) NO: K220684(Traditional)
ATTN: Rania  Saleh                PHONE NO : 202 7584111 
1001 Fairview Avenue North Suite 2SE DECISION MADE: 29-APR-22
Seattle WA  98109                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elite Biomedical Solutions Dose Request Cord
Elite Biomedical Solutions        510(k) NO: K220695(Traditional)
ATTN: Brenda  Compliment          PHONE NO : 855 2916701 214
756 Cincinnati-Batavia Pike Suite SE DECISION MADE: 29-APR-22
Cincinnati OH  45245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prestige Coil System
Bait USA, LLC                     510(k) NO: K220699(Special)
ATTN: Michael  Peters             PHONE NO : 949 7881443 
29 Parker                         SE DECISION MADE: 08-APR-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD Horizon™ Spinal System and PASS LP™ Spinal System
Medicrea International            510(k) NO: K220724(Special)
ATTN: Karine  Trogneux            PHONE NO : 33 472 018787 
5389 Route de Strasbourg - Vancia SE DECISION MADE: 08-APR-22
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)
Signature Orthopaedics Pty Ltd.   510(k) NO: K220737(Special)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 11-APR-22
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TeleScan
BB Imaging                        510(k) NO: K220767(Third Party - Traditional)
ATTN: Blanca  Lesmes              PHONE NO : 512 3516880 
9701 Brodie Lane, Suite 200       SE DECISION MADE: 14-APR-22
Austin TX  78748                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle  (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle,  4. Torque Handle (AC3205P)
Medtronic Vascular                510(k) NO: K220773(Special)
ATTN: Nikita Ciandra  Vaz         PHONE NO : 978 7396632 
37A Cherry Hill Drive             SE DECISION MADE: 13-APR-22
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XD
Mirada Medical Ltd                510(k) NO: K220779(Third Party - Traditional)
ATTN: Adam  Taylor                PHONE NO : 44 1865 817600 
New Barclay House, 234 Botley RoadSE DECISION MADE: 15-APR-22
Oxford  GB OX2 0HP                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FootHold System
CrossRoads Extremity Systems, LLC 510(k) NO: K220797(Traditional)
ATTN: Kim  Strohkirch             PHONE NO : 901 3612037 
6423 Shelby View Dr., Suite 101   SE DECISION MADE: 15-APR-22
Memphis TN  38134                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Drive Rail System
OrthoPediatrics Corp.             510(k) NO: K220809(Special)
ATTN: Yan  Li                     PHONE NO : 574 2670864 
2850 Frontier Drive               SE DECISION MADE: 08-APR-22
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinity™ OCT System and PASS OCT Spinal System
Medicrea International            510(k) NO: K220810(Special)
ATTN: Karine  Trogneux            PHONE NO : 33 472 018787 
5389 Route de Strasbourg - Vancia SE DECISION MADE: 19-APR-22
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1 Series Phototherapy Equipment
Daavlin Distributing Co.          510(k) NO: K220840(Special)
ATTN: Michele  Thiel              PHONE NO : 419 6366304 207
205 West Bement Street            SE DECISION MADE: 22-APR-22
Bryan OH  43506                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EKOS+ Endovascular Device
Boston Scientific                 510(k) NO: K220866(Special)
ATTN: Daniel  Root                PHONE NO : 408 5977460 
Two Scimed Place                  SE DECISION MADE: 20-APR-22
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nautilus
Dornier MedTech America, Inc      510(k) NO: K220871(Special)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts blvd, Suite 100      SE DECISION MADE: 18-APR-22
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saberscope5 Laparoscope
Xenocor, Inc                      510(k) NO: K220872(Special)
ATTN: Evan  Kelso                 PHONE NO : 616 2382988 
350 E. 400 S.,  Suite 401         SE DECISION MADE: 20-APR-22
Salt Lake City UT  84111          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExsoMed INnate NanoTM Lag Screw System
ExsoMed Corp.                     510(k) NO: K220892(Special)
ATTN: Reinhold  Toerek            PHONE NO : 216 4029304 
135 Columbia, Suite 201           SE DECISION MADE: 27-APR-22
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Strados Remote Electronic Stethoscope Platform (RESP)
Strados Labs, Inc.                510(k) NO: K220893(Third Party - Traditional)
ATTN: Nicholas  Delmonico         PHONE NO : 1 908 3100761 
1315 Walnut Street, Suite 1101    SE DECISION MADE: 27-APR-22
Philadelphia PA  19107            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
Stryker                           510(k) NO: K220895(Special)
ATTN: Marlene  Fraga              PHONE NO : 928 2949043 
5900 Optical Court                SE DECISION MADE: 22-APR-22
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Legion Inserts with JRNY Lock
Smith & Nephew, Inc.              510(k) NO: K220896(Special)
ATTN: Madison  Padgett            PHONE NO : 901 4568789 
7135 Goodlett Farms Parkway       SE DECISION MADE: 26-APR-22
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment Inc.        510(k) NO: K220898(Special)
ATTN: Dave  Loflin                PHONE NO : 412 8743315 
175 E Park Drive                  SE DECISION MADE: 27-APR-22
Tonawanda NY  14150               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oxehealth Vital Signs
Oxehealth Limited                 510(k) NO: K220899(Special)
ATTN: Iain  Charlton              PHONE NO : 44 7843 755490 
Magdalen Centre North, The Oxford SE DECISION MADE: 29-APR-22
Oxford  GB OX4 4GA                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Siemens Medical Solutions USA Inc.510(k) NO: K220939(Special)
ATTN: Alina  Goodman              PHONE NO : 1 224 5261404 
40 Liberty Blvd.                  SE DECISION MADE: 29-APR-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SURGIVISIO Device
Ecential Robotics                 510(k) NO: K220946(Special)
ATTN: Mathilde  Saulpic           PHONE NO : 0033 458 003586 
Zone Mayencin II, Parc Equation - SE DECISION MADE: 15-APR-22
Gieres  FR 38610                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EEA Circular Stapler with Tri-Staple Technology
Covidien                          510(k) NO: K221005(Special)
ATTN: Leo  Chen                   PHONE NO : 86 21 33230182 
Rooms 501, 502, 601, 602, No.3 buiSE DECISION MADE: 29-APR-22
Shanghai  CN 201114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GIA Stapler with Tri-Staple Technology
Covidien                          510(k) NO: K221006(Special)
ATTN: Yanjun  Jiao                PHONE NO : 86 21 33230126 
Room 501, 502, 601, 602 No.3 BuildSE DECISION MADE: 29-APR-22
Min Hang District, Shanghai  CN 20510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
Shockwave Medical, Inc.           510(k) NO: K221041(Special)
ATTN: Soraya L Hori               PHONE NO : 574 3068801 
5403 Betsy Ross Drive             SE DECISION MADE: 25-APR-22
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

        TOTAL 510(k)s THIS PERIOD   256                                     
        TOTAL WITH SUMMARIES        234                                     
        TOTAL WITH STATEMENTS        22
                                      
 
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