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  1. 510(k) Clearances

February 2022 510(K) Clearances

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


DEVICE: CardioChek Plus Test System; CardioChek Plus Home Test System
Polymer Technology Systems, Inc. d510(k) NO: K193406(Traditional)
ATTN: Margo  Enright              PHONE NO : 317 8705610 1012
4600 Anson Boulevard              SE DECISION MADE: 26-FEB-22
Whitestown IN  46075              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELEC-LED
MICRO-NX Co., Ltd.                510(k) NO: K201191(Traditional)
ATTN: Jong-Kun  Kee               PHONE NO : 82 53 6501000 
22 Maeyeo-ro 1gil, Dong-gu        SE DECISION MADE: 07-FEB-22
Daegu  KR 41059                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NATtrol BD MAX Vaginal Panel External Controls
Zeptometrix                       510(k) NO: K201403(Traditional)
ATTN: Shawn  Smith                PHONE NO : 716 8820920 
878 Main Street                   SE DECISION MADE: 02-FEB-22
Buffalo NY  14202                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Traufix osteosynthesis, osteotomy, and arthrodesis devices
Fixier, S.A. de C.V.              510(k) NO: K201510(Traditional)
ATTN: Vianey Mariana Perez Suarez PHONE NO : 477 7180018 
Calle Joaquín Pardavé No. 223 ColoSE DECISION MADE: 18-FEB-22
Leon  MX C.P. 37170               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NervAlign Nerve Cuff
Renerve Ltd                       510(k) NO: K202234(Traditional)
ATTN: David  Rhodes               PHONE NO : 
Suite 3, 21 Vale Street           SE DECISION MADE: 10-FEB-22
North Melbourne  AU 3051          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acetaminophen
Sekisui Diagnostics P.E.I. INC.   510(k) NO: K202644(Traditional)
ATTN: Penny  White                PHONE NO : 902 6280934 
70 Watts Avenue                   SE DECISION MADE: 18-FEB-22
Charlottetown  CA C1E 2B9         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Action Trackchair Hawk
Action Manufacturing Inc.         510(k) NO: K202728(Traditional)
ATTN: Alan  Macht                 PHONE NO : 507 5325940 
1105 Lake Road                    SE DECISION MADE: 10-FEB-22
Marshall MN  56258                510(k) STATEMENT
                                                    

DEVICE: Bodygard SFS Surgical Gown Level 3
Feliks Plastik Laminasyon Ve Ambal510(k) NO: K202845(Traditional)
ATTN: Ali Serdar Serteser         PHONE NO : 90 22 22362353 
Eskisehir Industrial Zone 26 th StSE DECISION MADE: 24-FEB-22
Eskisehir  TR 26100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Micro Catheter
Shanghai Heartcare Medical Technol510(k) NO: K202926(Traditional)
ATTN: Zongyu  Xue                 PHONE NO : 86 18 621683501 
590 Ruiqing Rd, Building 4, Suite SE DECISION MADE: 10-FEB-22
Shanghai  CN 201201               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinity Acute Care System (IACS) Monitoring System
Draeger Medical Systems, Inc.     510(k) NO: K203088(Traditional)
ATTN: Deborah  Herrington         PHONE NO : 978 3798002 
6 Tech Dr.                        SE DECISION MADE: 01-FEB-22
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo SedLine Sedation Monitor and Accessories
Masimo Corporation                510(k) NO: K203113(Traditional)
ATTN: Sindura  Penubarthi         PHONE NO : 949 3964041 
52 Discovery                      SE DECISION MADE: 25-FEB-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cool-tip RF Ablation System E Series
Covidien LLC                      510(k) NO: K203150(Traditional)
ATTN: Liron Bar Yaakov            PHONE NO : 303 5816668 
5920 Longbow Drive                SE DECISION MADE: 25-FEB-22
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
Tandem Diabetes Care, Inc.        510(k) NO: K203234(Traditional)
ATTN: Ashley  Reynolds            PHONE NO : 858 3666900 
11075 Roselle Street              SE DECISION MADE: 15-FEB-22
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaScrew Extension
Medacta International SA          510(k) NO: K203335(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 03-FEB-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PainTB, PainTJ
Ptech Co., Ltd.                   510(k) NO: K203337(Traditional)
ATTN: Yosung  Choi                PHONE NO : 82 10 40517344 
35, Wondogok-gil, Poseung-eup     SE DECISION MADE: 11-FEB-22
Pyeongtaek-si  KR 13449           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Okamoto 002 Lubricated Polyurethane Male Condom
Okamoto U.S.A. Inc.               510(k) NO: K203541(Traditional)
ATTN: Yu  Tadano                  PHONE NO : 203 3780003 301
18 King Street                    SE DECISION MADE: 25-FEB-22
Stratford CT  06615               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoArmor™ + Surgical Gown
Boston Scientific Corporation     510(k) NO: K203548(Traditional)
ATTN: Laura  Kuroski              PHONE NO : 508 6834406 
100 Boston Scientific Way         SE DECISION MADE: 21-FEB-22
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoSerter-PL
CorneaGen, Inc                    510(k) NO: K203586(Traditional)
ATTN: Tom  Miller                 PHONE NO : 206 2763864 1058
101 N. Chestnut Street, Suite 303 SE DECISION MADE: 02-FEB-22
Winston Salem NC  27101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RithmID-SD Steerable Diagnostic Electrophysiology Catheter
Synaptic Medical Corporation      510(k) NO: K203793(Traditional)
ATTN: Charles  Yang               PHONE NO : 760 6088388 
1817  Aston Ave Suite 101         SE DECISION MADE: 14-FEB-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GPC Intraheal Intramedullary Nailing System
GPC Medical Limited               510(k) NO: K203811(Traditional)
ATTN: Vikas  Narang               PHONE NO : 91 11 43222600 
GPC Square, M-Block, DDA LSC, VikaSE DECISION MADE: 10-FEB-22
New Delhi  IN 110018              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
3M Health Care Business Group     510(k) NO: K210135(Traditional)
ATTN: Margaret  Marsh             PHONE NO : 210 2556481 
3M Centre, Cain Road              SE DECISION MADE: 24-FEB-22
Berkshire, Bracknell Forest  GB RG510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Titan Condoms
Titan Condoms LLC                 510(k) NO: K210208(Traditional)
ATTN: Neville  Muringayi          PHONE NO : 951 7466130 
1950 Elkhorn Ct. Unit. 210        SE DECISION MADE: 17-FEB-22
San Mateo CA  94403               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Auto-Disable Syringes with/without Needle for Single Use
Zhejiang Kangkang Medical-Devices 510(k) NO: K210229(Traditional)
ATTN: Chun  Guo                   PHONE NO : 1358 6180908 
Longwang Industrial District, ChumSE DECISION MADE: 15-FEB-22
Yuhuan  CN 317605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Noris Medical Dental Implants System
Noris Medical Ltd                 510(k) NO: K210356(Traditional)
ATTN: Simha  Sibony               PHONE NO : 972 73 7964477 
8 Hataasia                        SE DECISION MADE: 04-FEB-22
Nesher  IL 3688808                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Morpheus
S4S UK Ltd.                       510(k) NO: K210636(Traditional)
ATTN: Matthew  Everatt            PHONE NO : 44 114 2500176 
151 Rutland Road                  SE DECISION MADE: 15-FEB-22
Sheffield  GB S3 9PT              510(k) STATEMENT
                                                    

DEVICE: HotDog Warming Mattress + Return Electrode
Augustine Temperature Management L510(k) NO: K210727(Abbreviated)
ATTN: Temi  Ogunse                PHONE NO : 952 4653539 
7656 West 78th Street             SE DECISION MADE: 01-FEB-22
Minneapolis MN  55439             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Healing Abutment, Cover Screw
MegaGen Implant Co., Ltd.         510(k) NO: K210826(Traditional)
ATTN: You Jung Kim                PHONE NO : 82 53 2222828 
45, Secheon-ro, 7-gil             SE DECISION MADE: 03-FEB-22
Daegu  KR 42921                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOCLEAN CLEANsert Ultrasonic Insert
TTBIO CORP.                       510(k) NO: K210832(Traditional)
ATTN: Sheng-Chieh  Su             PHONE NO : 886 423595958 
2F, No.7, 6th Road, Industry Park SE DECISION MADE: 02-FEB-22
Taichung  TW 40755                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Pen Needle
Sandstone Medical (Suzhou) Inc.   510(k) NO: K210864(Traditional)
ATTN: Juanjuan  Sun               PHONE NO : 86 512 65799368 
No.168 PuTuoShan Road, New DistricSE DECISION MADE: 17-FEB-22
Suzhou  CN 215153                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Breast Pump
Shantou Huihengqi Electronic Techn510(k) NO: K211024(Traditional)
ATTN: Gensong  Yang               PHONE NO : 86 0754 88893348 
501, 5/F, Block C, 14A Industrial SE DECISION MADE: 11-FEB-22
Shantou  CN 515000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LoFric Elle
Dentsply Sirona                   510(k) NO: K211212(Traditional)
ATTN: Rebecca  Sporer             PHONE NO : 717 4954286 
221 W Philadelphia Street, Suite 6SE DECISION MADE: 17-FEB-22
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rosso
Quanta System SpA                 510(k) NO: K211228(Traditional)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 676797 
Via Acquedotto 109                SE DECISION MADE: 02-FEB-22
Samarate  IT Varese               510(k) STATEMENT
                                                    

DEVICE: ArtUs
Telemed                           510(k) NO: K211248(Traditional)
ATTN: Yury  Sokolov               PHONE NO : 370 5 2106272 
Highway Business Centre Savanoriu SE DECISION MADE: 11-FEB-22
Vilnius  LT LT-03154              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPRI Corpectomy Cage System
K2M, Inc.                         510(k) NO: K211320(Traditional)
ATTN: Renee  Norby                PHONE NO : 201 7254954 
600 Hope Parkway SE               SE DECISION MADE: 24-FEB-22
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
CathRxLtd                         510(k) NO: K211327(Traditional)
ATTN: Lucy  Huang                 PHONE NO : 61 2 78041846 
Unit 8, 2-8 South St              SE DECISION MADE: 10-FEB-22
Rydalmere  AU 2116                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K211400(Traditional)
ATTN: Haiying  Zhao               PHONE NO : 86 10 88794631 
No.9 Shuangyuan Road, Badachu Hi-tSE DECISION MADE: 11-FEB-22
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F3D-C2 Cervical Stand-Alone System
CoreLink, LLC                     510(k) NO: K211417(Traditional)
ATTN: Steven  Mounts              PHONE NO : 888 3497808 
2072 Fenton Logistics Blvd.       SE DECISION MADE: 04-FEB-22
St. Louis MO  63026               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uLab Systems Dental Aligner Kit
uLab Systems, Inc.                510(k) NO: K211510(Traditional)
ATTN: Amir  Albolfathi            PHONE NO : 650 8041397 
1820 Gateway Drive, Suite 300     SE DECISION MADE: 24-FEB-22
San Mateo CA  94404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PathBuilder Steerable Introducer
Shanghai MicroPort EP MedTech Co.,510(k) NO: K211530(Traditional)
ATTN: Tian  Xia                   PHONE NO : 86 21 38954600 3613
Building 23&28, Lane 588, TianxionSE DECISION MADE: 08-FEB-22
Shanghai  CN 201318               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zeolite Hemostatic Gauze
Hangzhou Zeo-Innov Life Technology510(k) NO: K211570(Traditional)
ATTN: Lijuan  Zhao                PHONE NO : 86 571 86651470 
R101, Building 2, No.291 Fucheng RSE DECISION MADE: 10-FEB-22
Hangzhou  CN 310018               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
Pegavision Corporation            510(k) NO: K211603(Traditional)
ATTN: Estela  Lin                 PHONE NO : 886 3329 8808 
2F-1, No. 5 Shing Yeh St          SE DECISION MADE: 02-FEB-22
Taoyuan  TW 33341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fogarty Occlusion Catheter
Edwards Lifesciences, LLC         510(k) NO: K211610(Traditional)
ATTN: Anisha  Butala              PHONE NO : 949 2501004 
One Edwards Way                   SE DECISION MADE: 14-FEB-22
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrascanner
Infrascan, Inc.                   510(k) NO: K211617(Traditional)
ATTN: Baruch Ben Dor              PHONE NO : 215 3876784 
3508 Market Street                SE DECISION MADE: 09-FEB-22
Philadelphia PA  19104            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epione
Quantum Surgical SAS              510(k) NO: K211645(Traditional)
ATTN: Lagacherie  Elise           PHONE NO : 33 448 194050 
ZAC Eureka 1000 rue du Mas de VercSE DECISION MADE: 24-FEB-22
Montpellier  FR 34000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENFit enteral syringes (NUTRIFIT)
Pentaferte Italia S.R.L.          510(k) NO: K211661(Traditional)
ATTN: Rosa  Di Gioia              PHONE NO : 
Viale Piane Nocella, 23           SE DECISION MADE: 28-FEB-22
Campli  IT i-64012                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xtractor device
Xcardia Innovation Ltd.           510(k) NO: K211679(Traditional)
ATTN: Benny  Rousso               PHONE NO : 972 544 345653 
1 Hamada Street                   SE DECISION MADE: 17-FEB-22
Rehovot  IL 7670301               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexible Video-Choledo-Cysto-Ureteroscope System
Shanghai SeeGen Photoelectric Tech510(k) NO: K211686(Traditional)
ATTN: Yvonne  Fei                 PHONE NO : 0086 13 701701046 
3 Floor, Building No.1, 4299 JinDuSE DECISION MADE: 22-FEB-22
Shanghai  CN 201108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-Guide® Surgical Navigation System
X-Nav Technologies, LLC           510(k) NO: K211701(Traditional)
ATTN: Kimberly  Chan              PHONE NO : 267 4360414 
1555 Bustard Road, Suite 75       SE DECISION MADE: 01-FEB-22
Lansdale PA  19446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OmniTom Elite
NeuroLogica Corporation, a subsidi510(k) NO: K211711(Traditional)
ATTN: Ninad  Gujar                PHONE NO : 978 5648632 
Co., Ltd 14 Electronics Avenue    SE DECISION MADE: 25-FEB-22
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
Orthofix US LLC                   510(k) NO: K211712(Traditional)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 11-FEB-22
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
Canadian Pioneer Medical Technolog510(k) NO: K211722(Traditional)
ATTN: Rashid Reza Mir Reza Mir    PHONE NO : 1 437 7727788 
Unit 2 -210 Drumlin Circle, ConcorSE DECISION MADE: 25-FEB-22
Vaughan  CA L4K 3E3               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pocket Ultrasound System
GuangDong Youkey Medical Co., Ltd.510(k) NO: K211746(Traditional)
ATTN: Hu  Zeyi                    PHONE NO : 086 0757 86258600 
Unit 601, Block B, Building 1, B1 SE DECISION MADE: 18-FEB-22
Foshan  CN 528203                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cleaner Plus Thrombectomy System
Argon Medical Devices, Inc.       510(k) NO: K211798(Traditional)
ATTN: Ana  Jimenez-Hughes         PHONE NO : 903 6764276 
1445 Flat Creek Road              SE DECISION MADE: 24-FEB-22
Athens TX  75751                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LifePath Remote Patient Monitoring Platform
Elastic Care Incorporated         510(k) NO: K211822(Third Party - Traditional)
ATTN: Ashok  Kalle                PHONE NO : 416 7045141 
95 Apple Creek Blvd.              SE DECISION MADE: 03-FEB-22
Markham  CA L3R 1C7               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Ion Facet Screw System
SurGenTec, LLC                    510(k) NO: K211855(Traditional)
ATTN: Andrew  Shoup               PHONE NO : 561 9907882 
911 Clint Moore Rd                SE DECISION MADE: 25-FEB-22
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StimRouter Neuromodulation System
Bioness Inc.                      510(k) NO: K211965(Traditional)
ATTN: Sageev  George              PHONE NO : 661 3889303 
25103 Rye Canyon Loop             SE DECISION MADE: 23-FEB-22
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Powder Free Examination Glove
Top Glove Vietnam Company Limited 510(k) NO: K212011(Traditional)
ATTN: Natrisya Nur Binti Abdul RahPHONE NO : 60 333 623043 
Lot A_8B_CN, Street N3, Bau Bang ISE DECISION MADE: 14-FEB-22
Bau Bang  VN 75000                510(k) STATEMENT
                                                    

DEVICE: TeesuVac Breast Biopsy Device Mark 1
TeesuVac ApS                      510(k) NO: K212079(Traditional)
ATTN: John  Hvidkjaer             PHONE NO : 45 61 558399 
Agern Alle 3                      SE DECISION MADE: 02-FEB-22
Hoersholm  DK DK-2970             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
Vascular Solutions LLC            510(k) NO: K212167(Traditional)
ATTN: Beka  Vite                  PHONE NO : 763 7622601 
6464 Sycamore Court N             SE DECISION MADE: 09-FEB-22
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wearable Breast Pump (Model S12)
Shenzhen TPH Technology Co., Ltd. 510(k) NO: K212180(Traditional)
ATTN: Peter  Chen                 PHONE NO : 86 755 82703212 
Bulan Road, Nanwan Community, LongSE DECISION MADE: 11-FEB-22
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
Vascular Solutions LLC            510(k) NO: K212211(Traditional)
ATTN: Rebecca  Astrup             PHONE NO : 763 7622601 
6464 Sycamore Court N             SE DECISION MADE: 09-FEB-22
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multitom Rax with True2scale Body Scan Option
Siemens Medical Solutions         510(k) NO: K212212(Traditional)
ATTN: Denise  Adams               PHONE NO : 610 9442184 
40 Liberty Boulevard              SE DECISION MADE: 18-FEB-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
Cepheid                           510(k) NO: K212213(Traditional)
ATTN: Suzette  Chance             PHONE NO : 262 6231775 
904 Caribbean Drive               SE DECISION MADE: 09-FEB-22
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: smart-sync
northh medical GmbH               510(k) NO: K212271(Traditional)
ATTN: Kai-Kristoph  Fehrs         PHONE NO : 49 176 24812117 
Roentgenstrasse 24                SE DECISION MADE: 04-FEB-22
Hamburg  DE 22335                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Shenzhen Mericonn Technology Co., 510(k) NO: K212300(Traditional)
ATTN: Jiang  Chuanyuan            PHONE NO : 0086 139 28416535 
Room 20203, Building 6, DonglongxiSE DECISION MADE: 25-FEB-22
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heartland Health Surgical Mask
Heartland Health Products         510(k) NO: K212366(Abbreviated)
ATTN: Frank  Fischer              PHONE NO : 513 8701611 
5389 East Provident Dr            SE DECISION MADE: 19-FEB-22
Cincinnati OH  45246              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arsenal Ankle Plating System
Trilliant Surgical                510(k) NO: K212378(Traditional)
ATTN: Sofia  Middleton            PHONE NO : 318 3939657 
727 North Shepherd Drive, Suite 10SE DECISION MADE: 23-FEB-22
Houston TX  77007                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
Ethicon, Inc.                     510(k) NO: K212380(Traditional)
ATTN: Marife  Sevek               PHONE NO : 908 8086602 
1000 Route 202                    SE DECISION MADE: 22-FEB-22
Raritan NJ  08869                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ambu® aScope™ Gastro, Ambu® aBox™2
Ambu A/S                          510(k) NO: K212382(Traditional)
ATTN: Mette  Anderson             PHONE NO : 45 7225 2106 
Baltorpbakken 13                  SE DECISION MADE: 03-FEB-22
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
Shenzhen VitaVitro Biotech Co.,Ltd510(k) NO: K212410(Traditional)
ATTN: Donghai  Pan                PHONE NO : 86 755 84511813 
R601, Building B, Hai Ke Xing TechSE DECISION MADE: 01-FEB-22
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magnifico Open, Magnifico MSK
Esaote S.p.A.                     510(k) NO: K212419(Traditional)
ATTN: Alberto  Carcagni           PHONE NO : 39 055 4229365 
Via Enrico Melen 77               SE DECISION MADE: 04-FEB-22
Genoa  IT 16152                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
Biomet, Inc.                      510(k) NO: K212431(Traditional)
ATTN: Gregory  Foster             PHONE NO : 574 3710519 
56 East Bell Drive PO Box 587     SE DECISION MADE: 07-FEB-22
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
Hangzhou Sejoy Electronics & Instr510(k) NO: K212447(Traditional)
ATTN: Yanyan  Zhang               PHONE NO : 86 571 81957767 
Area C, Building 2, No.365        SE DECISION MADE: 18-FEB-22
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexitSystem Knee osteotomy system
Neosteo                           510(k) NO: K212545(Traditional)
ATTN: JD  Webb                    PHONE NO : 33 02 36569670 
Malleve 2A, 1 Boulevard Jean MouliSE DECISION MADE: 11-FEB-22
Nantes  FR 44 100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoPlan System
OsteoMed LLC                      510(k) NO: K212570(Traditional)
ATTN: Diane  Rutherford           PHONE NO : 972 6774731 
3885 Arapaho Road                 SE DECISION MADE: 11-FEB-22
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amazing+
Amazing Rubber Products Pvt Ltd   510(k) NO: K212586(Abbreviated)
ATTN: Jayasankar  S               PHONE NO : 944 7053062 
Plot No 14c, Cochin Special EconomSE DECISION MADE: 17-FEB-22
Cochin  IN 682037                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CO2 Laser Equipment
Beijing Globalipl Development Co.,510(k) NO: K212611(Traditional)
ATTN: Liu  Jun                    PHONE NO : 86 151 69727366 
F-8 Qunyinghui Building, Jinyuan RSE DECISION MADE: 01-FEB-22
Beijing  CN 102628                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zyter RPM
Zyter, Inc.                       510(k) NO: K212622(Traditional)
ATTN: Lakshmi Narayana Babu       PHONE NO : 240 4269647 
2600 Tower Oaks Blvd. Suite 700   SE DECISION MADE: 11-FEB-22
Rockville MD  20852               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True Tulip, True M.I.S.
Innovative Surgical Designs, Inc. 510(k) NO: K212627(Special)
ATTN: Jon  Rinehart               PHONE NO : 217 8368522 103
3903 S. Walnut St.                SE DECISION MADE: 18-FEB-22
Bloomington IN  47401             510(k) STATEMENT
                                                    

DEVICE: Micro C Medical Imaging System, M01
OXOS Medical, Inc.                510(k) NO: K212654(Third Party - Traditional)
ATTN: Evan  Ruff                  PHONE NO : 855 7339729 
1230 Peachtree Street NE, Suite 30SE DECISION MADE: 04-FEB-22
Atlanta GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CloudCath Peritoneal Dialysis Drain Set Monitoring System
CloudCath                         510(k) NO: K212658(Traditional)
ATTN: Brian  Fisher               PHONE NO : 415 6513393 
665 3rd Street, Suite 250         SE DECISION MADE: 09-FEB-22
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sclerotherapy Needle
Zhejiang Chuangxiang Medical Techn510(k) NO: K212668(Traditional)
ATTN: Lucius  Long                PHONE NO : 86 571 89167088 
                                  SE DECISION MADE: 23-FEB-22
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Actively Trying Personal Lubricant Unfragrance
CC Wellness LLC                   510(k) NO: K212705(Traditional)
ATTN: Marlent  Perez              PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 09-FEB-22
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genex Bone Graft Substitute
Biocomposites Ltd                 510(k) NO: K212721(Traditional)
ATTN: Simon  Fitzer               PHONE NO : 440 1782 338580 
Keele Science Park                SE DECISION MADE: 04-FEB-22
Keele  GB ST5 5NL                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Vacutainer UltraTouch Push Button Blood Collection Set
Becton, Dickinson and Company     510(k) NO: K212724(Traditional)
ATTN: Katherine Kenner Lemus      PHONE NO : 732 31448624 
1 Becton Drive                    SE DECISION MADE: 04-FEB-22
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VenSure LightGuide
Intersect ENT                     510(k) NO: K212774(Traditional)
ATTN: Yoko  Enrile                PHONE NO : 650 6813143 
1555 Adams Dr.                    SE DECISION MADE: 04-FEB-22
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LevaLap Laparoscopic Access Device
Core Access Surgical Technologies,510(k) NO: K212786(Traditional)
ATTN: Marianne D. Jacklyn         PHONE NO : 503 5037299633 
3495 Piedmont Road, NE Building 11SE DECISION MADE: 23-FEB-22
Atlanta GA  30305                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRIMA Humeral System and SMR Glenosphere Ø42
LimaCorporate S.p.A.              510(k) NO: K212800(Traditional)
ATTN: Antonia  Trevisan           PHONE NO : 
Via Nazionale 52                  SE DECISION MADE: 25-FEB-22
Villanova di San Daniele del friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bluezone Model RX-450 Air Purifier
Bluezone Products, Inc.           510(k) NO: K212824(Traditional)
ATTN: Karen  Benedek              PHONE NO : 781 9370202 
225 Wildwood Avenue               SE DECISION MADE: 17-FEB-22
Woburn MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Examination Gloves
Chifeng Huawei Medical Science & T510(k) NO: K212833(Traditional)
ATTN: Li  Xiaohong                PHONE NO : 86 182 480565694 
No. 2-4, Second-stage StandardizedSE DECISION MADE: 28-FEB-22
Chifeng  CN 024023                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
bioMérieux, Inc                   510(k) NO: K212849(Special)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Rd.                    SE DECISION MADE: 04-FEB-22
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Taiwan Comfort Champ Manufacturing510(k) NO: K212863(Traditional)
ATTN: Jen  Ke-Min                 PHONE NO : 886 3 3637999 
No. 55, Aly. 51, Ln. 50, Daren Rd.SE DECISION MADE: 19-FEB-22
Taoyuan City  TW 33068            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Actively Trying Personal Lubricant Rose Scented
CC Wellness LLC                   510(k) NO: K212885(Traditional)
ATTN: Marlent  Perez              PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 11-FEB-22
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Broncoflex Agile, Broncoflex Vortex, Screeni
Axess Vision Technology           510(k) NO: K212886(Traditional)
ATTN: Marie-Hélène  Bacheley      PHONE NO : 33 02 47343290 
Zone de la Liodière 6, rue de la FSE DECISION MADE: 16-FEB-22
Joué-lès-Tours  FR 37300          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LumiVy Lumbar IBF System
Vy Spine, LLC                     510(k) NO: K212930(Traditional)
ATTN: Jordan  Hendrickson         PHONE NO : 866 4897746 
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 16-FEB-22
Tallahassee FL  32308             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air Pressure Foot Massager
Xiamen Simo Electronic Co., Ltd   510(k) NO: K212935(Traditional)
ATTN: Wang  Qinsheng              PHONE NO : 86 138 60109615 
Floor 3rd-5th, No. 173 Siming ParkSE DECISION MADE: 19-FEB-22
Xia Men  CN 361100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use
Henan Nursecare Biotechnology Co.,510(k) NO: K212949(Abbreviated)
ATTN: Yaping  Zhang               PHONE NO : 86 373 5698686 
Building C1, Xindong Science Park,SE DECISION MADE: 24-FEB-22
Xinxiang  CN 453700               510(k) STATEMENT
                                                    

DEVICE: NPseal
Guard Medical Inc                 510(k) NO: K212971(Traditional)
ATTN: Machiel Van Der Leest       PHONE NO : 888 4173644 
1221 Brickwell Avenue, Suite 900  SE DECISION MADE: 10-FEB-22
Miami FL  33131                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
Cordis Corporation                510(k) NO: K212977(Traditional)
ATTN: Vidya  Venkataraghavan      PHONE NO : 408 7181348 
14201 N.W. 60th Avenue            SE DECISION MADE: 17-FEB-22
Miami Lakes FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (White, Blue and Black)
Alcatron Gloves Factory           510(k) NO: K212998(Traditional)
ATTN: Hui  Zhao                   PHONE NO : 0086 533 2197155 
NO. 12-1, Xing' an Road East, LinqSE DECISION MADE: 19-FEB-22
Weifang  CN 262600                510(k) STATEMENT
                                                    

DEVICE: Levator Elite (Model LE9011)
Shenzhen Dongdixin Technology Co.,510(k) NO: K213043(Traditional)
ATTN: Siping  Yuan                PHONE NO : 86 755 27652471 
Floor 1-2, No.3 Building, Fanshen SE DECISION MADE: 25-FEB-22
Shenzhen  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExamVue Duo
JPI Healthcare Co, Ltd.           510(k) NO: K213057(Traditional)
ATTN: Sam  Kang                   PHONE NO : 82 70 44454516 
608-Ho, 28, Digital-Ro 33-Gil, GurSE DECISION MADE: 18-FEB-22
Seoul  KR 08377                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: O'Star Nitrile Examination Gloves Powder Free
Star Investment And Trade Joint St510(k) NO: K213058(Traditional)
ATTN: Do Van Binh                 PHONE NO : 84 984 990992____ 
Khac Niem Industrial Cluster, KhacSE DECISION MADE: 08-FEB-22
Bac Ninh  VN 16000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ear Thermometer, Model ET001
Guangzhou Berrcom Medical Device C510(k) NO: K213079(Traditional)
ATTN: Zhigang  Du                 PHONE NO : 86 020 34938449 
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 18-FEB-22
Guangzhou  CN 51147               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ear Thermometer, Model ET005, ET008, ET009
Guangzhou Berrcom Medical Device C510(k) NO: K213084(Traditional)
ATTN: Zhigang  Du                 PHONE NO : 86 020 34938449 
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 25-FEB-22
Guangzhou  CN 51147               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Well-Life TENS/EMS/Heating Stimulator
Well-Life Healthcare Limited      510(k) NO: K213091(Traditional)
ATTN: Jenny  Hsieh                PHONE NO : 886 2 22266981 
6F., No.168, Lide St., Jhonghe DisSE DECISION MADE: 19-FEB-22
New Taipei City  TW 235           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Blue Nitrile Examination Gloves
Novid PPE Sdn. Bhd.               510(k) NO: K213107(Traditional)
ATTN: Er Chai Chuan               PHONE NO : 6 016 3689637 
Lot 6071, Jalan Haji Abdul Manan, SE DECISION MADE: 17-FEB-22
Klang  MY 41050                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid
iSchema View Inc.                 510(k) NO: K213165(Traditional)
ATTN: James  Rosa                 PHONE NO : 303 7043374 
433 Park Point Drive, Suite 220   SE DECISION MADE: 08-FEB-22
Golden CO  80401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoFlow Reinforced Ureteral Stent
Coloplast Corp                    510(k) NO: K213186(Traditional)
ATTN: Gayatri  Ghadge             PHONE NO : 612 4223206 
1601 West River Road North        SE DECISION MADE: 16-FEB-22
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
BioMerieux, Inc.                  510(k) NO: K213241(Traditional)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Road                   SE DECISION MADE: 25-FEB-22
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EONS Nitrile Examination Gloves Powder Free
Eons Gloves (Thailand) Co., Ltd   510(k) NO: K213286(Traditional)
ATTN: Gliaophan  Supharkarn       PHONE NO : 66 958 638585 
486/14 Moo 9 Nai Klong Bang Pla KoSE DECISION MADE: 19-FEB-22
Phra Samut Chedi  TH 10290        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Redline
Johns Dental Laboratories         510(k) NO: K213297(Traditional)
ATTN: Marni  Buis                 PHONE NO : 800 4570504 
423 S. 13th ST                    SE DECISION MADE: 09-FEB-22
Terre Haute IN  47807             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
Zibo Sinocare Plastic Products Co.510(k) NO: K213306(Traditional)
ATTN: Mila  Guo                   PHONE NO : 008 6533 7859433 
Lot 5, No. 21 Qingtian Road       SE DECISION MADE: 18-FEB-22
Zibo  CN 255414                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucy Breast Pump
Willow Innovations, Inc.          510(k) NO: K213311(Third Party - Traditional)
ATTN: Nelson  Lam                 PHONE NO : 925 9898681 
1975 W. El Camino Real, Suite 306 SE DECISION MADE: 09-FEB-22
Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Veinoflow SCD (Model: LBTK-M-I 5006)
Dalian Labtek Science & Developmen510(k) NO: K213313(Traditional)
ATTN: Yao  Cui                    PHONE NO : 86 411 84548445 
1-18-17, Liandong Street, AdvancedSE DECISION MADE: 09-FEB-22
Dalian  CN 116085                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viz ANEURYSM, Viz ANX
Viz.ai, Inc.                      510(k) NO: K213319(Traditional)
ATTN: Gregory  Ramina             PHONE NO : 239 8983105 
201 Mission St, 12th Floor        SE DECISION MADE: 18-FEB-22
San Francisco CA  94105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
Stryker GmbH                      510(k) NO: K213328(Traditional)
ATTN: Cindy  Leon                 PHONE NO : 201 8315374 
325 Corporate Drive               SE DECISION MADE: 11-FEB-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INLIANT Surgical Navigation System
Navigate Surgical Technologies Inc510(k) NO: K213392(Traditional)
ATTN: Marty  Dymek                PHONE NO : 949 3503722 
302 - 25 E. 6th Ave.              SE DECISION MADE: 22-FEB-22
Vancouver  CA V5T 1J3             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
Luliang Hongruida Health Protectio510(k) NO: K213440(Traditional)
ATTN: Zhang  Guocai               PHONE NO : 86 311 66766067 
Zhaokua Area, Luliang Industrial ZSE DECISION MADE: 18-FEB-22
Qujing  CN 655606                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzRay M18 (Model: VMX-P400)
Vatech Co., Ltd                   510(k) NO: K213462(Traditional)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799492 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 11-FEB-22
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON P500 Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K213487(Traditional)
ATTN: Sulgue  Choi                PHONE NO : 425 2819898 
22010 S.E. 51st Street            SE DECISION MADE: 11-FEB-22
Issaquah WA  98029                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TMG Nitrile Powder Free Examination Glove
Thai Medical Glove Co., Ltd.      510(k) NO: K213500(Traditional)
ATTN: Noppadol  Polbundit         PHONE NO : 66 38198102 
363/2 Moo 8, Tambol Bangphra      SE DECISION MADE: 21-FEB-22
Sriracha  TH 20110                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
Shenzhen AOJ Medical Technology Co510(k) NO: K213503(Traditional)
ATTN: Queena  Chen                PHONE NO : 86 755 27786026 
Room 301&4F, Blk A, Building A, JiSE DECISION MADE: 18-FEB-22
Shenzhen  CN 518126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Bio Compression Systems, Inc.     510(k) NO: K213533(Traditional)
ATTN: Marc  Somelofski            PHONE NO : 1 201 9390716 
120 West Commercial Ave           SE DECISION MADE: 16-FEB-22
Moonachie NJ  07074               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
Mercator Medical (Thailand) LTD   510(k) NO: K213548(Traditional)
ATTN: Praneet  Inthajak           PHONE NO : 66 74 584222 
88/8 Moo 12 Tambon Kampaengphet   SE DECISION MADE: 21-FEB-22
Amphur Rattaphum  TH 90180        510(k) STATEMENT
                                                    

DEVICE: Sentient Manufacturing Laser Fiber
Sentient Manufacturing  LLC       510(k) NO: K213554(Traditional)
ATTN: Jim  Mousseau               PHONE NO : 303 9029891 
4384 N Forestdale Dr., Suite 202  SE DECISION MADE: 02-FEB-22
Park City UT  84098               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JETi AIO Peripheral Thrombectomy System
Walk Vascular, LLC                510(k) NO: K213565(Traditional)
ATTN: Namratha  Manthani          PHONE NO : 408 2205786 
17171 Daimler Street              SE DECISION MADE: 01-FEB-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HOLLYWOOD SPECTRA Laser System
Lutronic Corporation              510(k) NO: K213569(Traditional)
ATTN: Haewon  Park                PHONE NO : 978 4474763 
Lutronic Center, 219, Sowon-Ro    SE DECISION MADE: 04-FEB-22
Deogyang-gu, Goyang-Si  KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PELNAC Wound Matrix
Gunze Limited                     510(k) NO: K213573(Traditional)
ATTN: Hidenori  Nishioka          PHONE NO : 81 773 428035 
46 Natsumegaichi, Aono            SE DECISION MADE: 09-FEB-22
Ayabe, Kyoto  JP 623-8513         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperLine
Dentium Co., Ltd.                 510(k) NO: K213599(Traditional)
ATTN: Eunsang  Lee                PHONE NO : 82 070 70987568 
76, Changnyong-daero 256beon-gil  SE DECISION MADE: 23-FEB-22
Suwon-si  KR 16229                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical nitrile examination gloves (Model: SH001)
Jiangxi SanHao Medical Instruments510(k) NO: K213600(Traditional)
ATTN: Wangfenfang  No Last Name prPHONE NO : 86 151 79660192 
Chengxi Industrial Park, Jishui CoSE DECISION MADE: 19-FEB-22
Ji'an  CN 331699                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGNA Artist Evo
GE Healthcare(Tianjin) Company Lim510(k) NO: K213603(Traditional)
ATTN: Qiang  Ding                 PHONE NO : 86 133 11385163 
No. 266 Jinjsan Road, Tianjin AirpSE DECISION MADE: 11-FEB-22
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EvoEndo Single-Use Endoscopy System
EvoEndo Inc                       510(k) NO: K213606(Traditional)
ATTN: Heather  Underwood          PHONE NO : 303 2237445 
12649 East Caley Ave, Suite 116   SE DECISION MADE: 14-FEB-22
Centennial CO  80111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Megasoft (China) Co., Ltd.        510(k) NO: K213617(Traditional)
ATTN: Sarah  Qiu                  PHONE NO : 86 188 59998002 
No.1 Xinqiang Road, Machinery PrinSE DECISION MADE: 11-FEB-22
Shishi  CN                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cionic Neural Sleeve NS-100
CIONIC                            510(k) NO: K213622(Traditional)
ATTN: Mihai  Ionescu              PHONE NO : 831 8244051 
1606 Stockton St, Suite #1        SE DECISION MADE: 14-FEB-22
San Francisco CA  94133           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Examination Gloves
Dezhou Hengchang Medical Technolog510(k) NO: K213625(Traditional)
ATTN: Jing  Li                    PHONE NO : 86 159 63319855 
West Side of South Tiandingfeng RoSE DECISION MADE: 17-FEB-22
Dezhou City  CN 251500            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instylla Delivery Kit
Instylla, Inc.                    510(k) NO: K213632(Special)
ATTN: Jennifer  Greer             PHONE NO : 781 6229293 
201 Burlington Road, North BuildinSE DECISION MADE: 10-FEB-22
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl/Nitrile Blend Exam Glove
Dezhou Hengchang Medical Technolog510(k) NO: K213634(Traditional)
ATTN: Jing  Li                    PHONE NO : 86 159 63319855 
West Side of South Tiandingfeng RoSE DECISION MADE: 18-FEB-22
Dezhou City  CN 251500            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vathin Video Bronchoscope System
Hunan Vathin Medical Instrument Co510(k) NO: K213635(Traditional)
ATTN: Feng  Yun                   PHONE NO : 86 1801 7856052 
1/F, Building 12, No.9 Chuanqi WesSE DECISION MADE: 28-FEB-22
Xiangtan  CN 411100               510(k) STATEMENT
                                                    

DEVICE: Durex Patronus Wide
RB Health (US) LLC                510(k) NO: K213647(Traditional)
ATTN: Kaitlyn  Chan               PHONE NO : 862 3250012 
399 Interpace Pkwy                SE DECISION MADE: 17-FEB-22
Parsippany NJ  07054-1133         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Reline Cervical System
NuVasive, Incorporated            510(k) NO: K213654(Traditional)
ATTN: Sali  Gully                 PHONE NO : 858 9093360 
7475 Lusk Boulevard               SE DECISION MADE: 23-FEB-22
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: B. Braun Introcan Safety 2 IV Catheter
B. Braun Medical Inc.             510(k) NO: K213664(Special)
ATTN: Tracy  Larish               PHONE NO : 
901 Marcon Blvd.                  SE DECISION MADE: 11-FEB-22
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves (Model: ZMG1351)
Wuhan Zonsen Medical Products Co.,510(k) NO: K213688(Traditional)
ATTN: Cynthia  Ye                 PHONE NO : 86 27 82737771 
No 8 Jinchao Road, Zhucheng StreetSE DECISION MADE: 18-FEB-22
Wuhan  CN 431400                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson P6, Voluson P8
GE Healthcare                     510(k) NO: K213689(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 17-FEB-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc510(k) NO: K213693(Traditional)
ATTN: Karthik  Pillai             PHONE NO : 1 317 3718593 
40 Liberty Boulevard Mail Code 65-SE DECISION MADE: 25-FEB-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exeter® X3® RimFit® Cup
Howmedica Osteonics Corp., dba Str510(k) NO: K213701(Traditional)
ATTN: Lin  Song                   PHONE NO : 201 2480177 
325 Corporate Drive               SE DECISION MADE: 01-FEB-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
Intuitive Surgical, Inc.          510(k) NO: K213710(Traditional)
ATTN: Connor  McCarty             PHONE NO : 805 7984205 
1266 Kifer Road                   SE DECISION MADE: 17-FEB-22
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgical Mask
Hunan Zhenheyikang Medical Instrum510(k) NO: K213724(Traditional)
ATTN: Yilin  Yin                  PHONE NO : 86 0731 58262222 
No.6 Building Jingxiang Energy,No.SE DECISION MADE: 20-FEB-22
Xiangtan  CN 411100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VyLink™ Spinal Screw System
Vy Spine, LLC                     510(k) NO: K213750(Traditional)
ATTN: Jordan  Hendrickson         PHONE NO : 866 4897746 
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 28-FEB-22
Tallahassee FL  32308             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Resorbable Fixation System
Stryker Leibinger Micro Implants  510(k) NO: K213777(Special)
ATTN: Gregory  Gohl               PHONE NO : 269 3701476 
750 Trade Centre Way -Suite 200   SE DECISION MADE: 04-FEB-22
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Veuron-Brain-pAb2
Heuron Co., Ltd.                  510(k) NO: K213801(Traditional)
ATTN: Dong Hoon Shin              PHONE NO : 82 32 4298508 
10th Floor, 7, Mirae-ro, Namdong-gSE DECISION MADE: 04-FEB-22
lncheon  KR 21558                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PALACOS MV pro
Heraeus Medical GmbH              510(k) NO: K213812(Traditional)
ATTN: Ljuba  Jaeckel              PHONE NO : 49 6181 353138 
Philipp-Reis-Str. 8/13            SE DECISION MADE: 02-FEB-22
Wehrheim  DE 61273                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viveve 2.0 System
Viveve, Inc.                      510(k) NO: K213814(Traditional)
ATTN: Kevin  Robison              PHONE NO : 317 4358898 
345 Inverness Drive South, BuildinSE DECISION MADE: 02-FEB-22
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonopet iQ Ultrasonic Aspirator System
Stryker Corporation               510(k) NO: K213824(Special)
ATTN: Thomas  Flannelly           PHONE NO : 011 353 876487949 
4100 East Milham Ave.             SE DECISION MADE: 03-FEB-22
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Home use hair removal device, model: Precise Touch Pro
Iluminage Beauty Co., Limited     510(k) NO: K213830(Traditional)
ATTN: Jacky  Lee                  PHONE NO : 86 135 10584309 
Level 54, Hopewell Centre, 183 QueSE DECISION MADE: 01-FEB-22
Wan Chai  HK 999077               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAVERICK External Fixation System
Smith & Nephew, Inc.              510(k) NO: K213874(Traditional)
ATTN: Brad  Sheals                PHONE NO : 901 2887141 
7135 Goodlett Farms Parkway       SE DECISION MADE: 11-FEB-22
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMICRYL Impression Materials
IMICRYL Dis Malzemeleri San. Ve Ti510(k) NO: K213890(Traditional)
ATTN: Husamettin  Sonmez          PHONE NO : 90 444 7130 120
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 11-FEB-22
KONYA  TR 42030                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Examination Gloves
Jiangsu Maolin Medical Technology 510(k) NO: K213912(Traditional)
ATTN: Yuan  Mao                   PHONE NO : 86 158 52683277 
29 Yuexiang Road, Yuecheng Town   SE DECISION MADE: 19-FEB-22
Jiangyin  CN 214404               510(k) STATEMENT
                                                    

DEVICE: DeGen Navigated Instrumentation
DeGen Medical                     510(k) NO: K213918(Traditional)
ATTN: Craig  Black                PHONE NO : 843 9924551 
1321-C North Cashua Drive         SE DECISION MADE: 09-FEB-22
Florence SC  29501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolution Ascend
GE Healthcare Japan Corporation   510(k) NO: K213938(Traditional)
ATTN: He  Haibo                   PHONE NO : 
7-127, 4-Chome, Asahigaoka,       SE DECISION MADE: 04-FEB-22
Hino  JP 191-8503                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Annalise Enterprise CXR Triage Pneumothorax
Annalise-AI                       510(k) NO: K213941(Traditional)
ATTN: Eric  Qin                   PHONE NO : 61 2 72040817 
Level 21, 60 Margaret Street      SE DECISION MADE: 24-FEB-22
Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
GE Healthcare Information Technolo510(k) NO: K213972(Third Party - Traditional)
ATTN: James T Turner              PHONE NO : 414 4919895 
9900 Innovation Dr.               SE DECISION MADE: 17-FEB-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Contour ProtégéAI
MIM Software Inc.                 510(k) NO: K213976(Special)
ATTN: Lynn  Hanigan               PHONE NO : 216 4550600 
25800 Science Park Drive – Suite 1SE DECISION MADE: 03-FEB-22
Cleveland OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
Pacific Instruments               510(k) NO: K213982(Traditional)
ATTN: Tracy  Sullivan             PHONE NO : 808 9418880 
438 Hobron Ln, Ste 204            SE DECISION MADE: 17-FEB-22
Honolulu HI  96815                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enbio S
Enbio Group AG                    510(k) NO: K213991(Special)
ATTN: Lukasz  Rogowski            PHONE NO : 48 605 058629 
Eichengasse 3                     SE DECISION MADE: 22-FEB-22
Oensingen  CH CH-4702             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deep Learning Image Reconstruction
GE Medical Systems, LLC.          510(k) NO: K213999(Traditional)
ATTN: Amy  Yang                   PHONE NO : 414 3513904 
3000 N. Grandview Blvd.           SE DECISION MADE: 18-FEB-22
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Zirconia Pre-shaded Block
Shenzhen Yurucheng Dental Material510(k) NO: K214003(Traditional)
ATTN: Fiya  Liao                  PHONE NO : 86 177 27849963 
101-201, Building 4, No.1 Branch oSE DECISION MADE: 18-FEB-22
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zirconia Dental Ceramics
Shenzhen Yurucheng Dental Material510(k) NO: K214005(Traditional)
ATTN: Fiya  Liao                  PHONE NO : 86 177 27849963 
101-201, Building 4, No.1 Branch oSE DECISION MADE: 18-FEB-22
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers
Medtronic Sofamor Danek USA, INC. 510(k) NO: K214011(Special)
ATTN: Alex  Underberg             PHONE NO : 901 3441443 
1800 Pyramid Place                SE DECISION MADE: 09-FEB-22
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accu-Chek Softclix Blood Lancing System
Roche Diabetes Care, Inc.         510(k) NO: K214022(Traditional)
ATTN: Cameron  Smith              PHONE NO : 317 6961965 
9115 Hague Road                   SE DECISION MADE: 17-FEB-22
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 14HQ901G-B
LG Electronics Inc.               510(k) NO: K214044(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 318 0665641 
77, Sanho-daero                   SE DECISION MADE: 16-FEB-22
Gumi-si  KR 39381                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radialis PET Camera
Radialis Inc.                     510(k) NO: K214062(Third Party - Traditional)
ATTN: Michael  Waterston          PHONE NO : 1 800 6013177 
Suite 2300B, 290 Munro Street     SE DECISION MADE: 04-FEB-22
Thunder Bay  CA P7A 7T1           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FEops HEARTguide
FEops nv                          510(k) NO: K214066(Traditional)
ATTN: Peter  Mortier              PHONE NO : 32 929 28030 
Technologiepark 122               SE DECISION MADE: 25-FEB-22
Gent-Zwijnaarde  BE 9052          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROKI Surgical Mask
ROKI Co., Ltd.                    510(k) NO: K214094(Traditional)
ATTN: Takamasa  Murata            PHONE NO : 81 53 9260550 
2396 Futamata, Futamata-Cho, TenrySE DECISION MADE: 24-FEB-22
Hamamatsu-shi  JP 431-3314        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Explorer Air II
SurgVision GmbH                   510(k) NO: K214097(Traditional)
ATTN: Daniela  Mahan              PHONE NO : 49 157 85116008 
Kistlerhof Strasse 70, Building 79SE DECISION MADE: 25-FEB-22
Munich  DE 81379                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luminice
Premier North America Inc.        510(k) NO: K214100(Traditional)
ATTN: Ellis  Tamari               PHONE NO : 404 492813311 
3301 SW 42nd Street               SE DECISION MADE: 24-FEB-22
Fort Lauderdale FL  33312-6828    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glidewell Appliance Resin, Hard/Soft
Prismatik Dentalcraft, Inc.       510(k) NO: K214102(Traditional)
ATTN: Jiahe  Li                   PHONE NO : 949 2223516 
2144 Michelson Drive              SE DECISION MADE: 23-FEB-22
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs
Mah Sing Healthcare Sdn Bhd       510(k) NO: K214110(Traditional)
ATTN: Sazalinda  Musa             PHONE NO : 603 3396 2288 
Wisma Mah Sing, Penthouse Suite 1,SE DECISION MADE: 19-FEB-22
Kuala Lumpur  MY 57100            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzOrtho v1.3
Ewoosoft Co., Ltd                 510(k) NO: K220003(Traditional)
ATTN: Young Seok Kim              PHONE NO : 82 31 80156172 
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 23-FEB-22
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pure-Vu EVS System
Motus GI Medical Technologies Ltd.510(k) NO: K220007(Special)
ATTN: Mark  Pomeranz              PHONE NO : 908 7458599 
22 Keren Ha'yesod Str.            SE DECISION MADE: 10-FEB-22
Tirat Carmel  IL 3902638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cryo 7
Zimmer MedizinSysteme GmbH        510(k) NO: K220020(Special)
ATTN: Ute  Killet                 PHONE NO : 49 731 9761216 
Junkersstrasse 9                  SE DECISION MADE: 04-FEB-22
Neu-Ulm  DE 89231                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NightOwl
Ectosense nv                      510(k) NO: K220028(Special)
ATTN: Bart  Van Pee               PHONE NO : 32 2 5889044 
Bosbessenlaan 19A                 SE DECISION MADE: 24-FEB-22
Rotselaar  BE 3110                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQCross Qx Integrated Transseptal Dilator/Needle
Acutus Medical, Inc.              510(k) NO: K220047(Third Party - Traditional)
ATTN: Sarah  Clay                 PHONE NO : 949 2917811 
2210 Faraday Ave, Suite 100       SE DECISION MADE: 08-FEB-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
FUJIFILM Corporation              510(k) NO: K220053(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 04-FEB-22
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
CooperVision, Inc.                510(k) NO: K220070(Special)
ATTN: Marie  Dutton               PHONE NO : 
6101 Bollinger Canyon Road, Suite SE DECISION MADE: 04-FEB-22
San Ramon CA  94583               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soniquence Reusable Neutral Plate
Soniquence, LLC                   510(k) NO: K220071(Special)
ATTN: Suzanne  Lucas              PHONE NO : 516 6341370 
2477 Grand Avenue                 SE DECISION MADE: 03-FEB-22
Baldwin NY  11510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Radiography CXDI-Pro, Digital Radiography D1
Canon Inc.                        510(k) NO: K220098(Special)
ATTN: Akira  Hirai                PHONE NO : 81 33 7582111 
9-1 Imaikami-Cho, Nakahara-Ku     SE DECISION MADE: 04-FEB-22
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SDC4K Information Management System with Device and Voice Control Package
Stryker Endoscopy                 510(k) NO: K220108(Special)
ATTN: Divya  Sekar                PHONE NO : 669 2044851 
5900 Optical Ct                   SE DECISION MADE: 09-FEB-22
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YandR System, VoluDerm Handpiece, VoluDerm Tips
Pollogen Ltd.                     510(k) NO: K220124(Special)
ATTN: Sharon  Ravid               PHONE NO : 972 3 5104410 
6 Kaufman Street                  SE DECISION MADE: 17-FEB-22
Tel Aviv  IL 6801298              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc.     510(k) NO: K220136(Special)
ATTN: Kristina  Hall              PHONE NO : 904 3735940 
203 Fort Wade Rd., Suite 150      SE DECISION MADE: 16-FEB-22
Ponte Vedra FL  32081             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lunderquist Extra Stiff Wire Guide
William Cook Europe ApS           510(k) NO: K220137(Special)
ATTN: Mie  Dyrholm                PHONE NO : 45 56 868492 
Sandet 6                          SE DECISION MADE: 17-FEB-22
Bjaeverskov  DK 4632              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aspiron S ACP System
U&I Corporation                   510(k) NO: K220147(Special)
ATTN: So-yeon  Jang               PHONE NO : 82 31 8606836 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 16-FEB-22
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS & PMS (Model: SM9126)
Hong Qiangxing (Shen Zhen) Electro510(k) NO: K220150(Third Party - Traditional)
ATTN: Xu  Jianhua                 PHONE NO : 86 755 26423665 
4F, Jingcheng Building, Xicheng InSE DECISION MADE: 17-FEB-22
Shenzhen  CN 518126               510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
Hycor Biomedical                  510(k) NO: K220162(Traditional)
ATTN: Irene M. Guzman             PHONE NO : 714 9333052 
7272 Chapman Avenue               SE DECISION MADE: 18-FEB-22
Garden Grove CA  92841            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trigon HA Wedge Fixation System
Nvision Biomedical Technologies, I510(k) NO: K220197(Special)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4590 Lockhill Selma               SE DECISION MADE: 23-FEB-22
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Normatec 3
NormaTec Industries, LP           510(k) NO: K220217(Third Party - Traditional)
ATTN: Steve  Henderson            PHONE NO : 800 3350960 
480 Pleasant Street, Suite A200   SE DECISION MADE: 25-FEB-22
Watertown MA  02472               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
Megine Industries Sdn Bhd         510(k) NO: K220232(Third Party - Special)
ATTN: Benjamin  Ng Soong Jing     PHONE NO : 60 112 6808828 
B-05-02, The Vertical Business SuiSE DECISION MADE: 20-FEB-22
Kuala Lumpur  MY 59200            510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: Cohitech Cottonlock Tampons with Reusable Applicator
Cotton High Tech, S.L.            510(k) NO: K220238(Special)
ATTN: Anna  Garcia Llado          PHONE NO : 34 9383 91628 
Colonia La Rabeia, S/N            SE DECISION MADE: 25-FEB-22
Balsareny  ES 08660               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Permadyne
3M Deutschland GmbH               510(k) NO: K220257(Third Party - Traditional)
ATTN: Ruediger  Franke            PHONE NO : 49 815 27001802 
ESPE Platz                        SE DECISION MADE: 01-FEB-22
Seefeld  DE 82229                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Digital Intraoral X-ray Sensor
Shenzhen Xpectvision Technology Co510(k) NO: K220277(Traditional)
ATTN: Mengsi  Peng                PHONE NO : 86 0755 26897621 
B507,Block A and B,Nanshan MedicalSE DECISION MADE: 17-FEB-22
Shenzhen  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArtiSential Laparoscopic Instruments-Electrodes
LivsMed Inc.                      510(k) NO: K220384(Special)
ATTN: Dong  Wook Lee              PHONE NO : 82 70 77094993 
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 24-FEB-22
Seongnam-si  KR 13516             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apapro Desensitizer
Sangi Co, Ltd                     510(k) NO: K220419(Third Party - Traditional)
ATTN: Douglas  Mercadante         PHONE NO : 81 70 26802931 
3-11-6 Tsukiji, Chuo-ku           SE DECISION MADE: 16-FEB-22
Tokyo  JP 104-8440                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VALO X, VALO X Accessory Lenses
Ultradent Products, Inc.          510(k) NO: K220471(Third Party - Traditional)
ATTN: Adam  Black                 PHONE NO : 801 5534425 
505 West Ultradent Drive (10200 SoSE DECISION MADE: 22-FEB-22
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

          TOTAL 510(k)s THIS PERIOD   203                                     
          TOTAL WITH SUMMARIES        191                                     
          TOTAL WITH STATEMENTS        12
                                      
 
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