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
