| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K211521 |
12/20/2021 |
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) |
3M Health Care Business Group |
Margaret Marsh |
| K212789 |
12/01/2021 |
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) |
5R MED Instruments (CHENGDU) Co., Ltd. |
Yuzhang Pan |
| K203069 |
02/08/2021 |
HydroMID |
Access Vascular Inc. |
Brian Hanley |
| K202101 |
12/29/2021 |
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Lev |
Accriva Diagnostics, Inc. |
Brian James |
| K210825 |
12/17/2021 |
Revitive Medic Coach (Model Number 5575AQ) |
Actegy, Ltd. |
Lawrence Brookfield |
| K210239 |
02/24/2021 |
CITRESPLINE and CITRELOCK ACL Implants |
Acuitive Technologies, Inc. |
Matthew Poggie |
| K203334 |
02/05/2021 |
The Citrefix Knotless Suture Anchor |
Acuitive Technologies, Inc. |
Matthew Poggie |
| K213538 |
12/30/2021 |
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A Bonafini |
| K210035 |
02/16/2021 |
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System |
Aegis Spine |
Kay Kwon |
| K211572 |
12/13/2021 |
Aesculap Slim Clip Applier |
Aesculap, Inc |
Paul Amudala |
| K211949 |
12/09/2021 |
AirStrip ONE Web Client with Alarm Communication Management (ACM) |
AirStrip Technologies, Inc. |
JF Lancelot |
| K203523 |
12/25/2021 |
Fixone hybrid knotless anchor |
AJU Pharm Co., Ltd. |
Kim Tae Hoon |
| K212806 |
12/28/2021 |
Alcon (serafilcon A) soft contact lenses for daily wear |
Alcon Laboratories, Inc |
Alicia Plesnarski |
| K213443 |
12/15/2021 |
InsigniaÖ Anterior Cervical Plate System |
Alphatec Spine, Inc. |
Sandy Gill |
| K213460 |
12/10/2021 |
Invictus Spinal Fixation System |
Alphatec Spine, Inc. |
Sandy Gill |
| K211457 |
12/18/2021 |
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) |
Ammex Corporation |
Sasitharan Nair |
| K201545 |
02/12/2021 |
Surgical Face Mask |
Amphastar Nanjing Pharmaceuticals, Inc. |
Bob Bao |
| K201231 |
02/02/2021 |
CTxx85 CT Scanner |
Analogic Corporation |
Laura Green |
| K201222 |
02/11/2021 |
Bio-C Repair Ion+ |
Angelus Industria de Produtos Odontologicos S/A |
Paulo Sergio Calixto de Oliveira |
| K213067 |
12/03/2021 |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
AngioDynamics, Inc. |
Kasey E Newcomb |
| K202188 |
02/19/2021 |
Safety Blood Collection Sets for Single Use |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Gang Yu |
| K213371 |
12/09/2021 |
Disposable Medical Nitrile Examination Gloves (Model:XYS-001) |
Anhui Xinyisheng Medical Technology Co.,Ltd |
Shyla Tang |
| K213176 |
12/13/2021 |
Disposable Nitrile Powder-Free Examination Gloves |
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. |
Kitty Xu |
| K202818 |
12/16/2021 |
Voyant Fine Fusion Device (EB230) |
Applied Medical |
Blake Stacy |
| K213627 |
12/17/2021 |
RF Vapor System |
Aqua Medical, Inc. |
Scott McGill |
| K213916 |
12/16/2021 |
ArchForm Orthodontic Software System |
ArchForm, Inc |
Andrew S. Martz |
| K213638 |
12/10/2021 |
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) |
Argon Medical Devices |
Ana Jimenez-Hughes |
| K200567 |
02/26/2021 |
ASI Plethysmogrpah Analyzer |
Arterial Stiffness Inc. |
Jospeh Henry Shaw |
| K213644 |
12/17/2021 |
Arthrex Knotless Mini TightRopes |
Arthrex Inc. |
Rebecca R Homan |
| K203294 |
02/03/2021 |
Arthrex Pilon Fusion System |
Arthrex Inc. |
Samantha Passman |
| K210817 |
12/08/2021 |
C&B 5.0 Hybrid |
Arum Dentistry Co., Ltd |
Yongsup Lee |
| K203723 |
12/10/2021 |
Branchor Balloon Guide Catheter |
Asahi Intecc Co., Ltd |
Yasuyuki Kawahara |
| K211898 |
12/08/2021 |
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 |
Asahi Intecc Co., Ltd. |
Tomoya Eguchi |
| K193407 |
12/23/2021 |
Contour« next GEN Blood Glucose Monitoring System |
Ascensia Diabetes Care |
Colleen Burdel |
| K201104 |
02/26/2021 |
AsoAligner |
Aso International Manila, Inc. |
Hiromichi Takahashi |
| K213076 |
12/20/2021 |
AspenMed+ |
Aspen Glove Sdn. Bhd. |
Iskandar Basha Bin Abdul Kadir |
| K212645 |
12/16/2021 |
AT |
AT Glove Engineering SDN. BHD |
L. A. Choong |
| K211452 |
12/02/2021 |
Encevis |
Austrian Institute of Technology GmbH |
Tilmann Kluge |
| K210268 |
02/26/2021 |
LTJ Screws and Washer |
AzurMeds Inc. |
Jean-Marie Berger |
| K203524 |
02/25/2021 |
Surgical Masks |
Bain Medical Equipment (Guangzhou) Co., Ltd. |
Mu Fanzhen |
| K201408 |
02/18/2021 |
Demetra Analytics Toolkit |
Barco NV |
Julie Vandecandelaere |
| K210036 |
02/05/2021 |
Carnation Ambulatory Monitor (CAM) |
Bardy Diagnostics, Inc. |
Jocelyn Kersten |
| K211786 |
12/03/2021 |
Independent Corneal Viewing Chamber (IVC-21) |
Bausch + Lomb, Incorporated |
Heather Christie |
| K212302 |
12/07/2021 |
BAYLAB 3-Ply Surgical Mask (BEACON I) |
Baylab USA, LLC |
Ashley Park |
| K213156 |
12/08/2021 |
BD Nano 2nd Gen Pen Needle |
Becton, Dickinson and Company |
Mark William |
| K210978 |
12/22/2021 |
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle |
Becton, Dickinson and Company |
Nikita Abirami Mahendra Kumar |
| K211918 |
12/21/2021 |
iCOquit« Smokerlyzer« |
Bedfont Scientific Ltd |
Louise Bateman |
| K203695 |
12/17/2021 |
NObreath« |
Bedfont Scientific Ltd |
Louise Bateman |
| K201412 |
02/18/2021 |
BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit |
BEGO Implant Systems GmbH & Co. KG |
Bertrand Lecointe |
| K201720 |
02/18/2021 |
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire |
Beijing Bywave Sensing Medical Technology Co., Ltd. |
Lizhe Zhang |
| K212983 |
12/08/2021 |
Injectable Root Canal Bioceramic Sealer |
Beijing C-Root Dental Medical Devices Co., LTD. |
Bingmin Wu |
| K210174 |
02/04/2021 |
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set |
Bemer INT. AG |
Sandra Schwarzenberger |
| K203513 |
02/10/2021 |
SLENDERTONE Evolve Abs, Type 735 |
Bio-Medical Research Ltd |
Eoin Keating |
| K213411 |
12/22/2021 |
iSRÆobot Mona Lisa 2.0 |
Biobot Surgical Pte Ltd |
Lim Yan Shin |
| K213428 |
12/22/2021 |
EdgePro |
Biolase Inc. |
Ed Balcos |
| K212730 |
12/21/2021 |
BellaTek Encode Emergence Healing Abutments |
Biomet 3i LLC |
Krupal Patel |
| K210192 |
02/19/2021 |
A.L.P.S. Clavicle Plating System |
Biomet Inc. |
Kyle Ponce |
| K212435 |
12/10/2021 |
Comprehensive Humeral Fracture Positioning Sleeves |
Biomet Inc. |
Aishwarya Pandey |
| K202232 |
02/19/2021 |
Comprehensive Vault Reconstruction System |
Biomet Manufacturing Corp. |
Patricia Sandborn Beres |
| K213208 |
12/23/2021 |
Twist Drills |
Biomet Microfixation |
Mark Wladkowski |
| K203634 |
02/02/2021 |
BioPoly Great Toe Hemiarthroplasty Implant |
BioPoly, LLC |
Herb Schwartz |
| K210202 |
02/24/2021 |
BioWaveGO RX |
BioWave Corporation |
Bradford Siff |
| K193330 |
02/18/2021 |
Clue Birth Control |
BioWink GmbH |
Carrie Walter |
| K200675 |
02/10/2021 |
Hi bebe super (Models BT-150S and BT-150L) |
Bistos Co., Ltd. |
Hae Sun Jeong |
| K202174 |
02/10/2021 |
Digital NeuroPort Biopotential Signal Processing System |
Blackrock Microsystems |
Rachelle Frischknecht |
| K211847 |
12/20/2021 |
AdVance XP Male Sling System |
Boston Scientific Corporation |
Anuja Bhatt |
| K213422 |
12/14/2021 |
EkoSonic Endovascular Device, EKOS+ Endovascular Device |
Boston Scientific Corporation |
Ambreen Athar |
| K200276 |
02/06/2021 |
SPEAC System |
Brain Sentinel, Inc. |
Richard Waite |
| K212420 |
12/16/2021 |
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio |
Brainlab AG |
Chiara Cunico |
| K212840 |
12/11/2021 |
Nitrile Gloves (Model: NE01) |
BYD Auto Industry Company Limited |
Liu Jiangling |
| K212899 |
12/11/2021 |
Disposable Vinyl/Nitrile Blend Medical Examination Gloves |
Bytech(Dongtai) Co., Ltd. |
Wang Cheng |
| K210405 |
12/15/2021 |
ProTEC-USA EZDoff Gown |
Cadillac Products, Inc. |
Andrew Stone |
| K213728 |
12/15/2021 |
Serranator PTA Serration Balloon Catheter |
Cagent Vascular, LLC |
Carol Burns |
| K210033 |
02/26/2021 |
Laser Treatment System, Model: NYX and Grace |
Canadian Pioneer Medical Technology Corporation |
Rashid Reza Mirsayah |
| K212492 |
12/20/2021 |
Frax 1940 for Nordlys and Frax Pro |
Candela Corporation |
Rina Ordonez |
| K211217 |
12/16/2021 |
Profound Matrix |
Candela Corporation |
Jeffrey Churchill |
| K213305 |
12/01/2021 |
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F. Reyes |
| K203553 |
02/02/2021 |
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F Reyes |
| K203312 |
02/16/2021 |
Vitrea Software Package, VSTP-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K202788 |
12/23/2021 |
Sonomed IV, Sonomed V |
Carci Industria E Comercio De Aparelhos Cirurgicos E Orto |
Orlando Orlandi |
| K202995 |
02/19/2021 |
X-ray Flat Panel Detectors/CareView 3600RF |
CareRay Digital Medical System Co., Ltd. |
Leilei Li |
| K211156 |
12/29/2021 |
CONVIVO In Vivo Pathology Suite |
Carl Zeiss Meditec AG |
Juergen Berger |
| K201906 |
02/24/2021 |
Trinity ELE Plus and Trinity ELE Plus Pro |
Carol Cole Company dba NuFACE |
Danielle Barker Fernandes |
| K201680 |
02/19/2021 |
NuFACE Mini Plus |
Carole Cole Company |
Danielle Barker Fernandes |
| K202611 |
02/12/2021 |
Catalyst OrthoScience R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K213705 |
12/21/2021 |
DRSplus |
CenterVue SpA |
Luca Scienza |
| K211022 |
12/22/2021 |
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 |
Muhammad Abdul Rahman |
| K210827 |
12/14/2021 |
ZEPTO Precision Capsulotomy System |
Centricity Vision, Inc. |
Neal Hartman |
| K201967 |
02/26/2021 |
SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System |
Chison Medical Technologies Co., Ltd. |
Qifei Liu |
| K201968 |
02/26/2021 |
SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System |
Chison Medical Technologies Co., Ltd. |
Qifei Liu |
| K201971 |
02/25/2021 |
SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System |
Chison Medical Technologies Co., Ltd. |
Qifei Liu |
| K201969 |
02/25/2021 |
SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System |
Chison Medical Technologies Co., Ltd. |
Qifei Liu |
| K210744 |
12/14/2021 |
Surgical Mask |
Chongqing Pa Xijia Biotechnology Co., Ltd. |
Zheng Tao |
| K212716 |
12/27/2021 |
Dermoaroma Disposable Nitrile Examination Glove |
ChuZhou Harmony Gloves Medical Technology Co.,Ltd |
WeiHong Ou |
| K200943 |
12/17/2021 |
Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System |
CIRCA Scientific, LLC |
Fred Piazza |
| K202212 |
02/19/2021 |
TruPlan |
Circle Cardiovascular Imaging Inc. |
Shirantha Samarappuli |
| K213691 |
12/22/2021 |
Solas OR |
Cirdan Imaging Ltd |
Paul Matthews |
| K202956 |
02/26/2021 |
Erisma LP Navigated Instruments |
Clariance, SAS |
Fadwa Bahr |
| K213140 |
12/22/2021 |
Claritas iPET |
Claritas HealthTech Pte Ltd |
Devika Dutt |
| K211277 |
12/16/2021 |
Theia NPWT Foam Wound Dressing Kit |
Clear Choice Therapeutics, Inc. |
Bret Batchelder |
| K202048 |
02/23/2021 |
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App |
Cochlear Americas |
Krystal Haley |
| K201436 |
02/25/2021 |
Vortek Single Loop Ureteral Stent |
Coloplast Corp |
Cori Ragan |
| K210252 |
02/17/2021 |
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System |
Conformis Inc. |
Mary Kruitwagen |
| K202303 |
02/19/2021 |
CORE E3 Suction/irrigator |
ConMed Corporation |
Tina Mornak |
| K202420 |
02/25/2021 |
Infrared Forehead Thermometer |
Conmo Electronic Company Limited |
Ying Qi |
| K213136 |
12/24/2021 |
CPL Surgical Face Mask |
Control Print Limited |
Pankaj Sharma |
| K203670 |
02/16/2021 |
Extra Large Check-Flo Introducer |
Cook Incorporated |
Reuben Lidster |
| K193138 |
12/27/2021 |
Colibri System |
COPAN WASP S.r.l. |
Catalano Giovanna |
| K202167 |
02/26/2021 |
Brite Tip Radianz Guiding Sheath |
Cordis Corporation |
Crystal Placona |
| K212034 |
12/09/2021 |
LOSPA TKR System |
Corentec Co., Ltd. |
Seungri Kim |
| K211561 |
12/05/2021 |
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) |
Covidien, llc |
Megan Elliott |
| K203651 |
02/26/2021 |
Cuptimize |
Cuptimize, Inc. |
Noah Wollowick |
| K212442 |
12/03/2021 |
Cydar EV (Series B) and Cydar EV Maps |
Cydar Ltd. |
Vanisha Mistry |
| K192839 |
02/11/2021 |
DSP Implant System |
D.S.P Industrial Eireli |
Celio Gilson Netzel |
| K203462 |
02/19/2021 |
Advanced Dental Appliance |
DaSoft Partners |
Dante Togliatti |
| K211039 |
12/15/2021 |
BIT-Motion |
DDE MRI Solutions LTD |
Moti Sokolov |
| K203374 |
02/05/2021 |
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) |
de G÷tzen S.r.l. |
Dario Bandiera |
| K211772 |
12/06/2021 |
PMW01 Procedure Mask Level 1 |
Defender Safety Inc. |
Nahal Islam |
| K211804 |
12/06/2021 |
3Delta Crown |
DeltaMed GmbH |
Michael Zimmermann |
| K212548 |
12/06/2021 |
LUXEN CL Dental Liquid |
DENTALMAX Co., Ltd. |
Park Seung Bum |
| K210132 |
02/17/2021 |
s-Clean SQ-SL Implant System Regular |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K201387 |
02/26/2021 |
Ultrafast, Ultrafast Plus, Ultrafast Lite |
DentLight Inc. |
Richard Liu |
| K210167 |
02/19/2021 |
DELTA XTEND Reverse Shoulder System |
DePuy Orthopaedics Inc. |
Megan Bernier |
| K212466 |
12/09/2021 |
LVivo Seamless |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K210053 |
02/05/2021 |
LVivo Software Application |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K210272 |
02/09/2021 |
LIAISON Anti-HAV |
DiaSorin Inc. |
John C. Walker |
| K202574 |
02/18/2021 |
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus |
DiaSorin Inc. |
John C Walter |
| K202573 |
02/18/2021 |
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus |
DiaSorin Inc. |
John C Walter |
| K212221 |
12/13/2021 |
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer |
Diazyme Laboratories Inc. |
Chao Dou |
| K203290 |
02/05/2021 |
Bonelogic |
Disior Ltd |
Markku Laitinen |
| K203821 |
12/17/2021 |
Donagamex Blue Performance Protective Gown |
Dong Nai Garment Corporation (Donagamex) |
Bui The Kich |
| K210305 |
12/22/2021 |
Pulse Oximeter |
Dongguan Lingxin Technologies Co., LTD |
Cony Tang |
| K202549 |
02/26/2021 |
Solax Electric Scooter (Model: S202261B) |
Dongguan Prestige Sporting Goods Co., Ltd |
Zhang Zhao |
| K191897 |
02/10/2021 |
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) |
Dongguan Prestige Sporting Goods Co., Ltd. |
Zhang Zhao |
| K201764 |
12/09/2021 |
Infinity Acute Care System (IACS) Monitoring Solution |
Draeger Medical Systems, Inc. |
Tom Hirte |
| K201421 |
02/05/2021 |
Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons |
Dukal Corporation |
Megan Quevedo |
| K201732 |
02/16/2021 |
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On |
Dukal Corporation |
Megan Quevedo |
| K210931 |
12/17/2021 |
Libby IAAA v1.0 |
Dyad Medical, Inc. |
Ronny Shalev |
| K212859 |
12/20/2021 |
First Relief |
DyAnsys, Inc. |
Srini Nageshwar |
| K211263 |
12/30/2021 |
Intrelief |
EasyMed Instruments Co., Ltd. |
Jeffery (Tingjie Wu) Wu |
| K202514 |
02/25/2021 |
EchoS Family |
Echolight S.p.A. |
Giovanna De Masi |
| K202401 |
02/17/2021 |
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein |
ECO Medi Glove Sdn. Bhd |
Suresh Kumar |
| K202096 |
02/02/2021 |
3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On |
EcoGuard Inc. |
Fang Wang |
| K213463 |
12/16/2021 |
NightOwl |
Ectosense nv |
Bart Van Pee |
| K203490 |
02/10/2021 |
FORE-SIGHT ELITE Absolute Tissue Oximeter |
Edwards Lifesciences, LLC |
Michelle Ducca |
| K193662 |
02/11/2021 |
Ezlymph, Ezlymph M |
Eezcare Medical Corp |
Michelle C Mitchell |
| K203546 |
02/12/2021 |
gammaCore Sapphire |
Electrocore, Inc. |
Mike Romaniw |
| K202789 |
02/23/2021 |
Monaco Rtp System |
Elekta Solutions AB |
Irina Proutski |
| K212630 |
12/16/2021 |
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo |
Ellex Medical Pty Ltd |
Rashmi Pillay |
| K201860 |
02/19/2021 |
Elos Accurate Hybrid Base |
Elos Medtech Pinol A/S |
Tina Friis Poulsen |
| K203557 |
02/10/2021 |
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing |
Encore Medical, L.P. |
Teffany Hutto |
| K211309 |
12/07/2021 |
endomina system |
Endo Tools Therapeutics S.A. |
Marine Rouyer |
| K202281 |
02/12/2021 |
EDS Bioceramic Sealer (Bioseal) |
Essential Dental Systems |
Jason Guzman |
| K213512 |
12/07/2021 |
DERMABOND PRINEO Skin Closure System |
Ethicon, Inc. |
Noorhidayah Norizan |
| K202510 |
12/10/2021 |
AMG PMP Infant |
Eurosets S.r.l. |
Katia Vescovini |
| K213116 |
12/03/2021 |
Everyway Incontinence Stimulation System |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K203754 |
02/19/2021 |
Eustachi Ear Pressure Relief Device |
Exercore, LLC |
Kevin Connelly |
| K210077 |
12/17/2021 |
MED RF 4000 |
F Care Systems USA LLC |
Patrick Danciu |
| K210847 |
12/10/2021 |
UltraClear Fractional Laser System |
FA International, LP |
Sharon Timberlake |
| K212918 |
12/13/2021 |
Heat StimPlus |
Famidoc Technology Co., Ltd. |
Amos Zou |
| K212219 |
12/03/2021 |
AHI System |
Fifth Eye Inc. |
Jennifer A. Baird |
| K202616 |
02/19/2021 |
ClearCap Distal Attachment |
Finemedix Co., Ltd. |
Seok-Jun Ma |
| K211560 |
12/10/2021 |
Airvo Nebulizer Adapter |
Fisher & Paykel Healthcare Limited |
Reena Daken |
| K213094 |
12/22/2021 |
ID-500 iRestore Hair Growth System |
Freedom Laser Therapy, Inc. |
Wei-Chih (Kevin) Chen |
| K210089 |
02/11/2021 |
CATSmart, Automated Blood Processing Autotransfusion System |
Fresenius Kabi AG |
Deepak Mehta |
| K210063 |
02/05/2021 |
Freudenberg Surgical Mask |
Freudenberg Performance Materials LP |
Eberhard Link |
| K201652 |
02/22/2021 |
COBRA-OS Kit |
Front Line Medical Technologies, Inc. |
Asha Parekh |
| K212869 |
12/13/2021 |
Disposable Surgical Gown, Disposable Reinforced Surgical Gown |
Fugou County Shenxiang Manufacturing Co., LTD. |
Carina Si |
| K203103 |
02/09/2021 |
Synapse 3D, Synapse 3D Base Tools v6.1 |
Fujifilm Corporation |
Randy Vader |
| K212950 |
12/02/2021 |
FUJIFILM Video Laparoscope EL-R740M30 |
FUJIFILM Corporaton |
Randy Vader |
| K213763 |
12/27/2021 |
Sonosite PX Ultrasound System |
FUJIFILM Sonosite, Inc. |
Anoush Frankian |
| K201391 |
02/16/2021 |
Easytech« Anatomical Shoulder System |
FX Shoulder USA, Inc. |
Kathy Trier |
| K202338 |
02/17/2021 |
SpaceFlex Shoulder |
G21 Srl |
Filippo Foroni |
| K202872 |
02/04/2021 |
Prase PEEK Anterior Cervical Interbody Spacer |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K201628 |
02/12/2021 |
Panda iRes Warmer, Giraffe Warmer |
GE Healthcare |
Michelle Johnson |
| K200626 |
02/16/2021 |
VesselIQ Xpress |
GE Medical Systems SCS |
Elizabeth Mathew |
| K213715 |
12/17/2021 |
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition |
GE Medical Systems,LLC |
Katelyn Rowley |
| K202331 |
02/02/2021 |
Medical Face Mask |
Gemtier Medical (Shanghai) Inc |
Li Zhiqing |
| K202493 |
02/04/2021 |
Medical Face Mask |
Gemtier Medical (Shanghai) Inc |
Li Zhiqing |
| K203804 |
02/23/2021 |
Global Med Systems Milesman Compact Laser |
Global Med Systems SL |
Fernando Diez |
| K203278 |
02/02/2021 |
INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers |
Globus Medical Inc. |
Kelly Baker |
| K212914 |
12/22/2021 |
Glovmaster Nitrile Examination Glove Powder Free |
Glovmaster SDN. BHD. |
Zarina binti Hamid |
| K201379 |
02/19/2021 |
Artemis Proximal Femoral Nail System |
GLW, Inc. |
Arundhati Radhakrishnan |
| K202003 |
02/24/2021 |
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim |
GMP Medicare SDN BHD |
Noraini Binti |
| K203483 |
02/01/2021 |
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves |
Guilin HBM Health Protections, Inc. |
Pu Lei |
| K202627 |
02/03/2021 |
Medical Face Masks |
Guilin HBM Sanitary Protections, Inc |
Liu Xin |
| K211531 |
12/17/2021 |
Cordless Prophy System, Model: i-Polish |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Ning Jiakang |
| K203615 |
12/10/2021 |
Dental Scaler and Air Polisher |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Yiwei Wang |
| K201306 |
02/05/2021 |
HAMILTON-C3 |
Hamilton Medical AG |
Simone Haller |
| K201121 |
02/05/2021 |
Sphincterotome |
Hangzhou AGS MedTech Co., Ltd. |
Chunqi Han |
| K201536 |
02/10/2021 |
Infrared Forehead Thermometer |
Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. |
Jenny Li |
| K211159 |
12/30/2021 |
eco-x Series (eco-x, eco-x-s) |
HDX WILL Corp. |
Myoung-Joon Lee |
| K211114 |
12/15/2021 |
Will3D |
HDX WILL CORP. |
Kim In-Young |
| K212944 |
12/15/2021 |
Disposable Surgical Mask |
Heilongjiang Yinjia Medical Equipment Co., Ltd. |
Zhu Hongwei |
| K210331 |
12/21/2021 |
CardiaMend Pericardial and Epicardial Reconstruction Matrix |
Helios Cardio Inc. |
Yiannis Monovoukas |
| K212925 |
12/13/2021 |
Disposable Surgical Gown |
Henan Robestain Medical Products Co., Ltd. |
Yonghong Liu |
| K203332 |
02/25/2021 |
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C |
HeTaiDa Technology Co., Ltd. |
Tom Chen |
| K212802 |
12/02/2021 |
powder free nitrile examination glove - white, non-sterile |
Hong Seng Gloves Sdn Bhd |
Ho Chia Yao |
| K212804 |
12/01/2021 |
Powder free nitrile examination glove- blue, non-sterile |
Hong Seng Gloves Sdn Bhd |
Ho Chia Yao |
| K211629 |
12/08/2021 |
Infrared forehead thermometer LD-FT-100B |
Honsun (Nantong) Co., Ltd |
Iris Du |
| K213129 |
12/21/2021 |
Restoration Modular 115mm Conical Distal Stem |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Allison Byrne |
| K212922 |
12/10/2021 |
Nitrile Examination Gloves |
HSK Medical Apparatus Foshan China Co. LTD |
Zhao Zhongheng |
| K213048 |
12/18/2021 |
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Huayuan Medical Technology(Shangqiu) Co., Ltd. |
Huamei Wang |
| K212398 |
12/15/2021 |
Surgical Face Mask (Non-sterile) |
Hubei Kimsoul Industrial Co., Ltd |
Faming Zhang |
| K213092 |
12/15/2021 |
Cellusheet, Cellufil |
Human Biosciences, Inc. |
Jigar Patel |
| K203603 |
02/01/2021 |
Monopolar Hook |
Human Xtensions Ltd. |
Maija Wallenstein |
| K202111 |
02/26/2021 |
Medical infrared forehead thermometer |
Hunan Honggao Electronic Technolofy Co., Ltd. |
Rongfang Hu |
| K201425 |
02/19/2021 |
Disposable Intraoperative Probe (DIOP8) |
Huntleigh Healthcare Limited |
Steve Monks |
| K202097 |
02/02/2021 |
Fundus Camera |
Huvitz Co., Ltd. |
Hyung Min Heo |
| K211209 |
12/17/2021 |
Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves |
Hycare International Co., Ltd |
Tippawan Phongpheaw |
| K212182 |
12/11/2021 |
Iconic Nitrile Glove |
Iconic Medicare Sdn Bhd |
Tan Cho Chia |
| K202045 |
02/26/2021 |
imani i1 |
imani Co. |
Hyo-Soon Hwang |
| K203647 |
12/22/2021 |
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
Wenying (Jessica) Zhu |
| K203564 |
12/22/2021 |
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
Wenying (Jessica) Zhu |
| K203420 |
02/03/2021 |
EcoFit« Hip System |
Implantcast, GmbH |
Juliane Hoppner |
| K202511 |
02/02/2021 |
Disposable Medical Surgical Mask |
Improve Medical (HuNan) Co., Ltd. |
Wang Jing |
| K212872 |
12/17/2021 |
Avenger Radial Head System |
In2Bones USA, LLC |
Christine Scifert |
| K213069 |
12/13/2021 |
CoLink NeoFuse Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K210195 |
02/24/2021 |
Triever Catheters |
Inari Medical |
Ellen Nguyen |
| K213303 |
12/07/2021 |
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 |
Infraredx, Inc. |
Stephen Sum |
| K213397 |
12/17/2021 |
InkSpace Imaging Pediatric Body Array |
InkSpace Imaging, Inc. |
Peter Fischer |
| K212547 |
12/30/2021 |
Quick-Start Screws |
Innovate Orthopaedics Limited |
Alex Gutteridge |
| K212776 |
12/20/2021 |
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled |
Innovative Health, LLC. |
Rick Ferreira |
| K203355 |
02/12/2021 |
Straumann TLX Novaloc and Cementable Abutments |
Institut Straumann AG |
Laure Kuhner Borsenberger |
| K192742 |
02/12/2021 |
Straumann Variobase C |
Institut Straumann AG |
Gordon Dodds |
| K212088 |
12/23/2021 |
Integrity Implants Navigated Instruments |
Integrity Implants Inc. |
Lauren Kamer |
| K211721 |
12/02/2021 |
PS System |
Inter-Med, INC. |
Brett Arand |
| K211997 |
12/10/2021 |
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads |
Intuitive Surgical, Inc. |
Amrit Jaggi |
| K203632 |
02/10/2021 |
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K213766 |
12/23/2021 |
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T |
Invivo Corporation |
Ann Lebar |
| K210190 |
02/23/2021 |
ClotTriever Thrombectomy System |
Irani Medical, Inc. |
Larry Boucher |
| K201378 |
02/18/2021 |
3D Accuitomo 150N |
J. Morita USA, INC. |
Fujio Zushi |
| K213637 |
12/10/2021 |
JAZZ Solo sensor |
Jazz Imaging LLC dba JAZZ Imaging |
Todd C Miller |
| K212266 |
12/21/2021 |
FIX-C PEEK Anterior Cervical Interbody System |
Jeil Medical Corporation |
Dajung Lee |
| K202794 |
12/13/2021 |
Surgical face mask: F-Y1-A |
Jiande Chaomei Daily Chemicals Co., Ltd |
Zhu Lipin |
| K201356 |
02/12/2021 |
Plastic LOR Syringe |
Jiangsu Caina Medical Co., Ltd |
Jianwei Pan |
| K201324 |
02/05/2021 |
Antibacterial Bandage |
Jiangsu Excellence Medical Supplies Co., Ltd |
Yanhua Li |
| K202605 |
02/10/2021 |
Standard Procedure Mask, Standard Surgical Mask |
Jiangsu Medplus Non-woven Manufacturer Co., Ltd. |
Shuying An |
| K212639 |
12/08/2021 |
Disposable Medical Nitrile Examination Gloves (Non sterile) |
Jiangsu Nanfang Medical Co., Ltd |
Xia Li |
| K212921 |
12/24/2021 |
Nitrile Examination Golves Powder Free |
Jiangsu Standard Health Co.,Ltd |
Lu Tao |
| K210914 |
12/17/2021 |
Sterile Syringe for Single Use |
Jiangsu Suyun Medical Material Co., Ltd. |
Guangning Xu |
| K212919 |
12/15/2021 |
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Jiujiang Taixin Technology Co., Ltd. |
Li Xiaojie |
| K203635 |
02/05/2021 |
Patient Monitoring Cables |
JKH USA, LLC |
Bill Quanqin Dai |
| K212827 |
12/06/2021 |
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K212985 |
12/16/2021 |
6MP Color LCD Monitor CL-S600 |
JVCKENWOOD Corporation |
Hideki Tengeiji |
| K213209 |
12/28/2021 |
EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device |
K1 Medical LLC |
Walt Oko |
| K213115 |
12/06/2021 |
CHENA-C Spacer System |
Kahtnu Surgical, Inc |
Craig Wilcox |
| K212907 |
12/02/2021 |
Aimanfun Lumea Comfort, A-2789/A-3588 |
Kam Yuen Plastic Products Ltd. |
Anna Dan |
| K201600 |
12/10/2021 |
Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 |
Kangfu Medical Equipment Factory |
Jixiang Zhang |
| K212656 |
12/29/2021 |
Flexible Intubation Video Endoscope û Sterile (FIVE-S) |
KARL STORZ Endoscopy America |
Mario Trujillo |
| K201945 |
02/25/2021 |
KARL STORZ UDEL Sterilization Trays |
Karl Storz EndoscopyAmerica Inc |
Leigh Spotten |
| K213139 |
12/21/2021 |
SURGmatic S15 L Pro |
KaVo Dental GmbH |
Kerstin Henseler |
| DEN200005 |
12/03/2021 |
Klox Biophotonic LumiHeal System |
Klox Technlogies Inc. |
Daniela Jukic |
| K212616 |
12/16/2021 |
Koios DS |
Koios Medical, Inc. |
Patricia Setti-Laperch |
| K203743 |
12/10/2021 |
EXA |
Konica Minolta Healthcare Americas, Inc. |
Carolyn Russell |
| K210240 |
02/22/2021 |
Air Compression Therapy Device, model HW6007 |
Konliking Tech & Dev. Limited |
Jane Chen |
| K212613 |
12/21/2021 |
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) |
Koon Seng Sdn Bhd |
Jennifer Yeo |
| K212573 |
12/08/2021 |
PicoLO Premium |
Laseroptek Co., Ltd. |
Hong Chu |
| K210965 |
12/15/2021 |
reVive Light Therapy Essentials |
LED Technologies, Inc. |
Lloyd Nelson |
| K210968 |
12/21/2021 |
reVive Light Therapy Essentials |
LED Technologies, Inc. |
Lloyd Nelson |
| K200062 |
02/22/2021 |
Foot and Ankle System |
Leith Medical LLC |
Tim Leak |
| K213266 |
12/03/2021 |
Inspan ScrewLES Fusion System |
LESpine Innovations, LLC |
John Sullivan |
| K212295 |
12/03/2021 |
21HQ513D |
LG Electronics Inc. |
Jinhwan Jun |
| K212137 |
12/10/2021 |
X-Clever |
LG Electronics.Inc |
Jin-Hwan Jun |
| K200636 |
02/03/2021 |
AXUS ES-5 Electro-Acupuncture Device |
Lhasa OMS, INC. |
Colleen Pike |
| K202240 |
02/25/2021 |
Disposable Surgical Mask/Fluid Resistant Procedure Mask |
LHM Medical Technology (Hong Kong) Limited |
Frank Cheng |
| K211865 |
12/20/2021 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Liao Ning Shangwei Medical Products Co., Ltd. |
Zhu Hongqing |
| K211378 |
12/16/2021 |
LM Surgical Mask Level 3, LM Surgical Mask Level 2, |
Liberty Mask LLC |
Will Kincaid |
| K212903 |
12/15/2021 |
SIMPACT Sacroiliac Joint Fixation System |
Life Spine, Inc. |
Angela Batker |
| K202848 |
12/14/2021 |
S2 Pigment Removal System |
Lightsense Technologies Ltd |
Deganit Barak |
| K202898 |
12/30/2021 |
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System |
Lightstone Medical Products (Ningbo) Co Ltd |
Julian Zhu |
| K213381 |
12/17/2021 |
Physica system |
LimaCorporate S.p.A |
Ilaria Giannuzzi |
| K203475 |
02/05/2021 |
LimaCorporate Kirschner Wire |
Limacorporate S.p.A. |
Ilaria Giannuzzi |
| K212500 |
12/03/2021 |
ArtiSential Trocar |
LivsMed Inc. |
Dong Wook Lee |
| K210137 |
02/18/2021 |
EsoCheck Cell Collection Device |
Lucid Diagnostics, Inc. |
Lishan Aklog |
| DEN200028 |
02/23/2021 |
Lumenis Stellar M22 |
Lumenis Ltd. |
Shlomit Segman |
| K200320 |
02/05/2021 |
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K211487 |
12/08/2021 |
MAF Guard |
MAF Clothing Pvt Ltd Unit-3 |
Kirit Jagani |
| K212535 |
12/04/2021 |
Nitrile Powder Free Blue Examination Gloves, Non-Sterile |
Mah Sing Healthcare Sdn Bhd |
Azlan Hashim |
| K201799 |
02/12/2021 |
CleaniCal |
Maruchi |
Jang Sung Wook |
| K211959 |
12/01/2021 |
Milli Vaginal Dilator |
Materna Medical |
Kelly Ashfield |
| K201490 |
02/12/2021 |
Electro Flo 6 Airway Clearance System |
Med Systems, Inc. |
Susan B Davis |
| K200551 |
02/12/2021 |
MectaLIF Transforaminal TiPEEK |
Medacta Inernational SA |
Stefano Baj |
| K203493 |
02/22/2021 |
MectaLock Extension |
Medacta International SA |
Stefano Baj |
| K202568 |
12/20/2021 |
Mpact« 3D Metal Implants - DMLS Technology |
Medacta International SA |
Stefano Baj |
| K200589 |
02/19/2021 |
MyPAO Planning Report |
Medacta International SA |
Stefano Baj |
| K193280 |
02/12/2021 |
MedCAD« AccuPlate« Patient-Specific Plate |
MedCAD |
Brian Buss |
| K212349 |
12/10/2021 |
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves |
Medi Legion Sdn.Bhd |
N.S. Kumar |
| DEN200041 |
12/10/2021 |
Comfort Marker 2.0. |
Medical Precision B.V. |
Roland Kortenhorst |
| K201332 |
02/10/2021 |
Meditech ABPM-06 (BP6) |
Meditech Ltd. |
Gabor Kazi |
| K210992 |
12/23/2021 |
Altech« Exhalation Valve (Single Limb and Dual Limb) |
Meditera Tibbi Malzeme San Ve TIC AS |
Cenk Kilic Kalkan |
| K212258 |
12/03/2021 |
Medline Cardiovascular Procedure Kit |
Medline Industries, Inc. |
Stephanie Augsburg |
| K211612 |
12/10/2021 |
Medline UNITE REFLEX Dynamic Discs |
Medline Industries, Inc. |
Jennifer Mason |
| K213155 |
12/15/2021 |
RT-Mind-AI |
MedMind Technology Co., Ltd. |
Shaobin Wang |
| K203794 |
02/01/2021 |
HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture |
Medos International Sarl |
Elizabeth Messana |
| K203319 |
02/05/2021 |
SYMPHONYÖ OCT System |
Medos International Sarl |
Eric Zhu |
| K212397 |
12/22/2021 |
StealthStation S8 Cranial v2.0 |
Medtronic Navigation |
Carey Brenner |
| K212428 |
12/13/2021 |
Centerpiece Plate Fixation System |
Medtronic Sofamor Danek |
Diamond Wallace |
| K212524 |
12/08/2021 |
Anteralign Spinal System with Titan nanoLOCK Surface Technology |
Medtronic Sofamor Danek USA, INC. |
Elizabeth Hamilton |
| K213631 |
12/15/2021 |
Chocolate PTA Balloon Catheter |
Medtronic, Inc. |
Laura Hanson |
| DEN190022 |
02/26/2021 |
Hominis Surgical System |
Memic Innovative Surgery Ltd. |
Einav Yemini |
| K210976 |
12/23/2021 |
Curian Campy |
Meridian Bioscience, Inc. |
Heather Planck |
| K212817 |
12/15/2021 |
Merit Siege Vascular Plug |
Merit Medical System, Inc. |
Mark Mullaney |
| K212675 |
12/14/2021 |
Aspira Peritoneal Drainage System |
Merit Medical Systems, Inc. |
Jennifer Webb |
| K202822 |
12/15/2021 |
Helianthus |
Metaltronica Spa |
Gloria Pesce Delfino |
| K210099 |
12/21/2021 |
Meticuly Patient-Specific Titanium Mesh Implant |
Meticuly Co., Ltd. |
Peeranoot Lohwongwatana |
| K201501 |
02/23/2021 |
Veolity |
MeVis Medical Solutions AG |
Rolf Rzodeczko |
| K210388 |
12/13/2021 |
Non Sterile Nitrile Powder Free Examination Gloves û Blue, Green and Black color |
Mexpo International Inc. |
Tim Thai |
| K210114 |
02/16/2021 |
Rebar Micro Catheter |
Micro Therapeuatics, Inc. d/b/a ev3 Neurovascular |
Catherine Chiou |
| K202850 |
02/09/2021 |
Concerto Versa, Detachable Coil |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Rita De Rama |
| K210230 |
02/25/2021 |
Phenom Catheters |
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular |
Prerana Gurubasavaraj |
| K211172 |
12/17/2021 |
Single Use Electrosurgical Knife with Fluid Pump System |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K210934 |
12/01/2021 |
Sphincterotome / short-wire compatible, Sterile Sphincterotome |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K212852 |
12/06/2021 |
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle |
Micro-Tech(Nanjing) Co., Ltd. |
Cecilia Sun |
| K212060 |
12/13/2021 |
neXus Ultrasonic Surgical Aspirator System |
Misonix Inc. |
John Salerno |
| K212402 |
12/16/2021 |
MIVI Q Distal Access Catheter |
MIVI Neuroscience, Inc. |
Janel Hurtado |
| K210559 |
12/19/2021 |
ATOZ Mini-Screw |
MK Meditech Inc. |
SungChul Moon |
| K202339 |
02/23/2021 |
Molekule Air Mini, Molekule Air Mini + |
Molekule, Inc. |
Frank Bianco |
| K202404 |
12/22/2021 |
BoneMRI |
MRIguidance B.V |
Roel Raatgever |
| K201635 |
02/06/2021 |
MouthLab Vital Signs Monitoring System |
MultiSensor Diagnostics (dba Aidar Health) |
Sathya Elumalai |
| K212867 |
12/11/2021 |
Medical Surgical Mask |
Nanchang Kanghua Health Materials Co., Ltd |
Jiamin Wang |
| K203426 |
02/18/2021 |
Surgical Face Mask (non-sterile) |
Nantong Taiweishi Medical Technology Co., Ltd. |
Zhang Xuewen |
| K203191 |
02/12/2021 |
LYDUS Nitrile Examination Gloves, Powder Free |
Nathan Trading Co., Ltd |
Chansamone Saiyasak |
| K211750 |
12/20/2021 |
Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) |
National Bridge Industrial (S.Z.) Co., Ltd. |
Yang Haixiong |
| K212329 |
12/09/2021 |
Plasma IQ |
Neauvia North America, Inc |
Joy Willard |
| K210711 |
12/22/2021 |
Neocis Guidance System (NGS) with Yomi Plan v2.0.1 |
Neocis Inc. |
Dayana Manganese |
| K212340 |
12/17/2021 |
EMBOGUARD Balloon Guide Catheter |
Neuravi Limited |
Niall Fox |
| K203419 |
02/16/2021 |
Relivion |
Neurolief Ltd. |
Michal Kedar-Datel |
| K213543 |
12/10/2021 |
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health |
Neuronetics, Inc |
Fred Cowdery |
| K202803 |
12/16/2021 |
Activmotion S DTO |
Newclip Technics |
Gaelle LUSSORI |
| K213301 |
12/21/2021 |
InCore Subtalar System |
Nextremity Solutions, Inc. |
Elise Fox |
| K213530 |
12/09/2021 |
Nextra CH Cannulated Hammertoe System |
Nextremity Solutions, Inc. |
Elise Fox |
| K212050 |
12/01/2021 |
NGM WAVE PLIF Cage |
NGMedical GmbH |
Stella Hahn |
| K213316 |
12/29/2021 |
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K202990 |
02/25/2021 |
NinesMeasure |
Nines, Inc. |
Russell Stewart |
| K211458 |
12/30/2021 |
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers |
Ningbo VeryKind Medical Device Co., Ltd. |
Pengfei Hong |
| K203494 |
02/23/2021 |
Nissha Medical Technologies Neutral Electrodes |
Nissha Medical Technologies LTD |
Marcel Salchner |
| K211109 |
12/21/2021 |
N1 TiUltra TCC Implant System |
Nobel Biocare Services AG |
Bernice Jim |
| K212932 |
12/18/2021 |
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray |
Nobel Biocare Services AG |
Nick Lewis |
| K202988 |
02/25/2021 |
Tixel System |
Novoxel Ltd. |
Ronen Shavit |
| K203265 |
02/09/2021 |
nPro Surgical Mask |
NP Medical Inc |
Ruthann Rapp |
| K203714 |
12/23/2021 |
NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive C |
NuVasive, Incorporated |
Jessica LeBlanc |
| K202432 |
02/19/2021 |
MiniLoad Syringe |
OcuJect, LLC |
Rebecca K Pine |
| K212310 |
12/22/2021 |
EyeBOX (Model EBX-4) |
Oculogica, Inc. |
Rosina Samadani |
| K213207 |
12/22/2021 |
Sheath, Stopcock Accessory |
Olympus Winter & Ibe GmbH |
Katharina Campbell |
| K212890 |
12/13/2021 |
Nyquist.IQ |
Omega Medical Imaging, LLC |
John Newman |
| K203588 |
02/05/2021 |
ELEOSÖ Limb Salvage System |
Onkos Surgical |
Matthew Vernak |
| K212285 |
12/22/2021 |
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) |
Oriental Inspiration Limited |
Francis Ko |
| K202950 |
02/23/2021 |
StitchKit COMBO |
Origami Surgical |
John Gillespie |
| K211471 |
12/16/2021 |
Balanced Knee System Uni |
Ortho Development Corporation |
Divya Palan |
| K211086 |
12/21/2021 |
The ProgenÖ Trochanteric Nail System |
Ortho Development Corporation |
Divya Palan |
| K212381 |
12/06/2021 |
VersaTap, VersaLat, DueLock, VersaTi, MiniTi |
Ortho-Design (Pty) Ltd |
Dian Peach |
| K203477 |
02/25/2021 |
Classic |
Orthoapnea S.L. |
Jose Repolles Llecha |
| K202651 |
02/12/2021 |
NOA Sleep Apnea and Snoring Device |
Orthoapnea S.L. |
Jose Repolles Llecha |
| K210136 |
02/18/2021 |
PhantomMSK Hip |
OrthoGrid Systems, Inc |
Trevor Hafer |
| K203573 |
02/04/2021 |
RESPONSE Navigation Instruments |
OrthoPediatrics, Corp. |
Yan Li |
| K213596 |
12/21/2021 |
OSSIOfiber Compression Screw, 3.5mm |
OSSIO Ltd. |
Taly Lindner |
| K203479 |
02/24/2021 |
ExtremiLOCK Lateral Ankle Fusion Plates |
OsteoMed |
Andrew Johnson |
| K213733 |
12/16/2021 |
Ponto 5 SuperPower |
Oticon Medical AB |
Anja Ravn |
| K201182 |
02/19/2021 |
iMask Disposable Surgical Face Mask |
Pac-Dent, Inc. |
Jiahe Li |
| K203385 |
02/11/2021 |
TenoTac Soft Tissue Fixation System |
Paragon 28, Inc |
Haylie Hertz |
| K211770 |
12/25/2021 |
R3ACT Stabilization System |
Paragon 28, Inc. |
Haylie Hertz |
| K202662 |
02/22/2021 |
Parcus Titanium Interference Screws |
Parcus Medical, LLC |
Alejandra Anderson |
| K203091 |
02/12/2021 |
MucoLock Oral Gel |
PCCA, Inc. |
Gus Bassani |
| K210871 |
12/17/2021 |
PDO Max Suture with Dual Needle |
PDO MAX, Inc. |
Giovanna McCarthy |
| K211448 |
12/06/2021 |
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses |
Pegavision Corporation |
Estela Lin |
| K212848 |
12/27/2021 |
Sterile Latex Surgical Gloves Powder Free |
Pentavest Holdings Sdn Bhd |
Teng Boon Joo |
| K210323 |
02/26/2021 |
Indigo Aspiration System - Lightning Aspiration Tubing |
Penumbra, Inc. |
Micaela Victoria |
| K210083 |
02/09/2021 |
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 |
Penumbra, Inc. |
Teri Nguyen |
| K210916 |
12/03/2021 |
PVmed Contouring Software |
Perception Vision Medical Technologies LTD.CO. |
Chuanji Huang |
| K203578 |
02/25/2021 |
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System |
Perimeter Medical Imaging AI, Inc. |
Elizabeth Munro |
| K212864 |
12/01/2021 |
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T |
Philips Healthcare (Suzhou) Co., Ltd |
Seaman Shao |
| K212186 |
12/13/2021 |
Philips Radiology Smart Assistant |
Philips Medical Systems DMC GmbH |
Connie Pascual |
| K203020 |
02/26/2021 |
Spectral CT |
Philips Medical Systems Nederland B.V. |
Yaara Oltchik |
| K201743 |
02/23/2021 |
ClarifEye R1.0, ClarifEye Needle |
Philips Medical Systems Nederlands B.V. |
Owen Callaghan |
| K201583 |
02/09/2021 |
SmartCT R1.0 |
Philips Medical Systems, Nederland B.V. |
Maria Silos Viu |
| K203406 |
02/23/2021 |
Lumify Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Colin S. Jacob |
| K213016 |
12/28/2021 |
ATM Glove |
Phu Duc Huy Production Trading Services Corporation |
Tran Xuan Kiem |
| K200527 |
02/19/2021 |
pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur |
pjur group Luxembourg SA |
Andrea Giebel |
| K203665 |
02/25/2021 |
STOP U Model UXV Device |
Pollogen Ltd. |
Ayala Kamil |
| K210444 |
02/16/2021 |
EZ-Injec LDV Sterile Safety Needle |
Poonglim Pharmatech Inc. |
Cho Hee Min |
| K210443 |
02/16/2021 |
PLPT LDV (Low Dead Volume) Sterile Syringe |
Poonglim Pharmatech Inc. |
Cho Hee Min |
| K202184 |
02/24/2021 |
Practical Navigation Surgical Guidance System (PNSGS) |
Practical Navigation, LLC |
Brad Clayton |
| K212075 |
12/08/2021 |
ShurFit Lumbar Interbody System |
Precision Spine, Inc. |
Michael Dawson |
| K200301 |
02/03/2021 |
UNiTi ACDF Implant System |
Pressio, Inc. |
Joe Ritz |
| K203784 |
02/23/2021 |
PreXion3D Explorer PRO |
PreXion Corporation |
Hiroaki Takahashi |
| K210241 |
12/03/2021 |
ImplaStation |
Prodigident, Inc. |
Andrii Gromov |
| K210212 |
12/15/2021 |
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair |
Psychemedics Corporation |
Neil Stowe |
| K203299 |
02/02/2021 |
CellFX System |
Pulse Biosciences, Inc. |
William Knape |
| K212740 |
12/02/2021 |
Puravita Medical Fold Flat Surgical Mask |
Puravita M, LLC |
Jefferson Nemelka |
| DEN200017 |
02/26/2021 |
Q-Collar |
Q30 Sports Science, LLC |
Gary A. Greene |
| K201644 |
02/28/2021 |
QardioCore |
Qardio Inc. |
Rosario Iannella |
| K203582 |
02/04/2021 |
QUIBIM Precision Prostate (qp-Prostate) |
QUIBIM S.L. |
Angel Alberich Bayarri |
| K203424 |
12/17/2021 |
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 |
Qura S.r.l. |
Raffaella Tommasini |
| K212690 |
12/21/2021 |
qXR-BT |
Qure.ai Technologies |
Bunty Kundnani |
| K202175 |
12/02/2021 |
OxyLight 2.0 |
Raja Trading Company, Inc. |
Christine K. Powers |
| K202702 |
02/26/2021 |
FLARE Single-Use Surgical Laser Fiber |
Realton (Suzhou) Medical Technology Co., Ltd. |
Mingzhu Liu |
| K203745 |
12/02/2021 |
AURORA Evacuator +Coag |
Rebound Therapeutics |
Naomi Gong |
| K200176 |
12/15/2021 |
FREEDOM Integrated Syringe Infusion System |
Repro-Med Systems, Inc., dba KORU Medical Systems |
Cynthia Lacatena |
| K213776 |
12/29/2021 |
LiverSmart |
Resonance Health Analysis Services Pty Ltd |
Mitchell Wells |
| K212351 |
12/15/2021 |
Revolution Peripheral Atherectomy System |
Rex Medical, L.P. |
Colin Valentis |
| K193081 |
12/17/2021 |
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit |
Rheonix, Inc |
Richard Montagna |
| K203079 |
02/09/2021 |
MR Conditional Sticky Pad Electrode |
Rhythmlink International, LLC |
Gabriel Orsinger |
| K212898 |
12/16/2021 |
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs |
Rimba Glove SND BHD |
Zahari Bin Darus |
| K203740 |
02/12/2021 |
JuggerKnot Soft Anchor |
Riverpoint Medical |
Amanda Cole |
| K210234 |
02/16/2021 |
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Kaitlyn Hameister |
| K211842 |
12/20/2021 |
Servator M SALF Solution |
S.A.L.F. spa |
Carmelo Gagliano |
| K201292 |
02/11/2021 |
TRAUS SIP20 |
Saeshin Precision Co., Ltd. |
GungSan Nam |
| K193422 |
02/02/2021 |
Easydrip Pen Needle, Easydrip Plus Pen Needle |
Sandstone Medical (Suzhou) Inc. |
Juanjuan Sun |
| K203255 |
02/24/2021 |
4K UHD Laparoscope |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K212904 |
12/14/2021 |
SeaSpine WaveForm C Interbody System |
SeaSpine Orthopedics Corporation |
Hong Phan |
| K213359 |
12/09/2021 |
SeaSpine WaveForm, C Interbody System |
SeaSpine Orthopedics Corporation |
Hong Phan |
| K203537 |
02/01/2021 |
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems |
SEDECAL SA |
Ma Luisa Gomez de Aguero |
| K202368 |
02/12/2021 |
Infrared Thermometer |
Shandong Bittel Intelligent Technology Co., Ltd. |
Cui Shi |
| K212603 |
12/22/2021 |
Non Absorbable Surgical Nylon Suture |
Shandong Haidike Medical Product Co., Ltd. |
Lili Xu |
| K212436 |
12/23/2021 |
NBR Synthetic Nitrile Examination Gloves |
Shandong Langtai International Trade Co., Ltd. |
Ping Wang |
| K203439 |
02/26/2021 |
Disposable Vinyl Examination Gloves |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K202341 |
02/12/2021 |
Disposable Surgical Mask |
Shanghai Jianzhong Medical Packaging Co., Ltd. |
Nina Huang |
| K212235 |
12/06/2021 |
Surgical Face Mask |
Shanghai Yunqing Industrial Co., Ltd. |
Hulin No Last Name Provided |
| K212924 |
12/13/2021 |
Nitrile Examination Gloves |
Shanxi Nacosa Medical Technology Co.,Ltd |
Lu Yingying |
| K213144 |
12/22/2021 |
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors |
Shen Wei USA Inc. |
Cheryl Reep |
| K211185 |
12/20/2021 |
IPL Home Use Hair Removal Device |
Shenzhen Beauty Every Moment intelligent electric Co., Ltd. |
Luo Huajun |
| K213020 |
12/16/2021 |
IPL hair removal machine |
Shenzhen Borria Technology Co.,Ltd |
Li Zhenqiang |
| K213225 |
12/22/2021 |
Diode Laser System GP900A8, Diode Laser System GP900Q8 |
Shenzhen GSD Tech Co., Ltd. |
Huifang Yao |
| K213024 |
12/22/2021 |
Oren LED Perioral Light Therapy System |
Shenzhen Kaiyan Medical Co Ltd |
Alain Dijkstra |
| K202687 |
02/18/2021 |
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 |
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. |
Aaron Lin |
| K211942 |
12/13/2021 |
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) |
Shenzhen OSTO Technology Company Limited |
Li Yang |
| K203510 |
02/26/2021 |
IPL Hair removal |
Shenzhen Weikai Technology CO.,LTD |
Jing Li |
| K211886 |
12/02/2021 |
Clivia series Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co.Ltd. |
Jiang Xiaosan |
| K200470 |
02/05/2021 |
Shofu Block HC Hard |
Shofu Dental Corporation |
Mauro Malzyner |
| K203247 |
02/25/2021 |
iFuse-TORQÖ Implant System |
SI-BONE, Inc. |
Susan Noriega |
| K212085 |
12/11/2021 |
Siam NTD+ Nitrile Powder-Free Examination gloves |
Siam NTD Corporation Co., Ltd. |
Taweesak Waideemaneetrakoon |
| K213096 |
12/06/2021 |
Al-Rad Companion (Pulmonary) |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K210055 |
02/05/2021 |
Cios Alpha |
Siemens Medical Solutions USA, Inc. |
Cordell Fields |
| K213700 |
12/13/2021 |
MULTIX Impact, MULTIX Impact C |
Siemens Medical Solutions USA, Inc. |
Denise Adams |
| K210054 |
02/05/2021 |
Cios Spin |
Siemens Medical Systems USA, Inc. |
Cordell Fields |
| K213159 |
12/22/2021 |
Encore System |
Siesta Medical, Inc. |
Michael Kolber |
| K213045 |
12/21/2021 |
TearCare System |
Sight Sciences, Inc. |
Edward J. Sinclair |
| DEN200018 |
02/05/2021 |
eXciteOSA with remote and eXciteOSA without remote |
Signifier Medical Technologies |
Yasser Zayni |
| K201142 |
02/25/2021 |
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set |
Simplivia Healthcare Ltd. |
Shay Shaham |
| K200734 |
02/24/2021 |
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit |
Sirius Medical Systems B.V. |
Bram Schermers |
| K212834 |
12/30/2021 |
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) |
Siyang Threeguard Medical Supplies Co.,Ltd. |
Guo Hua |
| K202255 |
12/24/2021 |
Skypro, SP02 Mask (3) |
Skypro Medical Supplies Company |
Cyrus Wong |
| K210269 |
02/23/2021 |
PowerDot PD-01MT2 Muscle Stimulator |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K203393 |
02/01/2021 |
FAST-FIX FLEX |
Smith & Nephew, Inc. |
Crystal Morales |
| K203716 |
12/14/2021 |
PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System |
Smith and Nephew Medical Limited |
Steeve Lamvohee |
| K201274 |
02/19/2021 |
Ultrasonic Osteotomy Surgical System |
SMTP Technology Co., Ltd |
Songtao Zhan |
| K212770 |
12/21/2021 |
Vision |
SoftSmile, Inc. |
Khamzat Asabaev |
| K202498 |
02/18/2021 |
4CIS SARA Spine System, 4CIS VERTU Spine System |
Solco Biomedical Company India Private Limited |
Viral Sheth |
| K201863 |
02/18/2021 |
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape |
SOMATEX Medical Technologies GmbH |
David Vasmer |
| K203302 |
02/05/2021 |
GentleWave X |
Sonendo, Inc |
Lyle VerPlanck |
| DEN210024 |
12/21/2021 |
CavaClear Laser Sheath |
Spectranetics, Inc. |
Sondra Chandler |
| K212326 |
12/01/2021 |
AC Cream - Conductive paste |
Spes Medica S.r.l |
Giorgio Facco |
| K212781 |
12/15/2021 |
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate |
Spinal Simplicity LLC |
Adam Rogers |
| K201454 |
02/10/2021 |
DSG Connect Technology |
SpineGuard, S.A. |
Stephane Bette |
| K210155 |
02/19/2021 |
Duo Expandable Interbody Fusion System |
Spineology Inc. |
Andrew Adams |
| K202380 |
02/19/2021 |
Born PT-LIF Cage HA |
SpineworxX AG |
Aouda Ouzzaa |
| K212706 |
12/13/2021 |
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard |
Splintek, Inc. |
Thomas W. Brown |
| K212767 |
12/22/2021 |
SleepRight Select-Comfort Dental Guard |
Splintek, Inc. |
Thomas W. Brown |
| K212830 |
12/21/2021 |
CT3000Pro |
SRS Medical |
Lee Brody |
| K213479 |
12/23/2021 |
D▓RS and D▓RS 9090 |
Stephanix |
Sandie Perret |
| K202112 |
02/21/2021 |
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece |
Storz Medical AG |
Pavel Novak |
| K202942 |
02/08/2021 |
Straumann 4 mm Short Implants |
Straumann USA, LLC |
Chanrasmey N. White |
| K203055 |
02/09/2021 |
Stryker PEEK Customized Cranial Implant Kit |
Stryker |
Zainab Amini |
| K212055 |
12/16/2021 |
Connected OR Hub with Device and Voice Control |
Stryker Corporation |
Eugene Perelshteyn |
| K203568 |
02/01/2021 |
Hoffmann LRF System |
Stryker GmbH |
Sanja Jahr |
| K203819 |
02/26/2021 |
T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System |
Stryker GmbH |
Jemin Dedania |
| K203182 |
02/26/2021 |
SubtleMR |
Subtle Medical, Inc. |
Ajit Shankaranarayanan |
| K203522 |
02/22/2021 |
Surn5 Electrosurgical Argon Beam Generator and Accessories |
Surnic Corporation |
Helen Xie |
| K201316 |
02/26/2021 |
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) |
Suzhou Peaksonic Medical Technology Co., Ltd |
Calvin Ma |
| K203442 |
02/19/2021 |
Inbrace Orthodontic System |
Swift Health Systems, Inc. |
Alicia Mszyca |
| K202027 |
02/03/2021 |
Balex bone Expander System |
Taeyeon Medical Co., Ltd. |
Sin-Ae Kang |
| K213006 |
12/21/2021 |
Vinyl Examination Gloves |
Taian Hengchang Medical Technology Co.,Ltd. |
Jing Li |
| K210670 |
12/21/2021 |
BU-CAD |
TaiHao Medical Inc. |
Hsin Hung |
| K211773 |
12/02/2021 |
Single-use Surgical Mask |
Taiwan Seafood and Fish Corporation |
Eric Ly |
| K202151 |
02/03/2021 |
Smart SPACE Shoulder System |
TechMah Medical LLC |
Mohamed R. Mahfouz |
| K212538 |
12/14/2021 |
DESS Dental Implants |
Terrats Medical SL |
Roger Terrats |
| K212577 |
12/10/2021 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K211078 |
12/21/2021 |
Progreat Lambda |
Terumo Clinical Supply Co., Ltd. |
Vaibhav Sivaramakrishan |
| K213531 |
12/20/2021 |
TR BAND Radial Compression Device |
Terumo Medical Corporation |
Liang Lu |
| K213073 |
12/29/2021 |
Goody Gloves, Wincare, TBG Gloves |
Thai Rubber Gloves Co., Ltd |
Chalongkwan Wongsasuthikul |
| K212438 |
12/07/2021 |
Comfortpro |
Thai Rubber Industry Company Limited |
Chawalit Tiyadechachai |
| K212850 |
12/10/2021 |
ComfortPro Blue Nitrile Examination Gloves Powder Free |
Thai Rubber Industry Company Limited |
Supawadee Phoungthong |
| K210126 |
12/03/2021 |
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% |
The Ritedose Corporation |
Linda Valentine |
| K212155 |
12/21/2021 |
TheraFace LED |
Theragun, Inc. |
Jaime Sanchez |
| K201435 |
12/03/2021 |
Molecular Flow Simulations |
Therataxis, LLC |
Raghu Raghavan |
| K203741 |
12/20/2021 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K211539 |
12/15/2021 |
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K203468 |
12/20/2021 |
TCAT TKA Instrument Tray |
THINK Surgical, Inc. |
George J. Prendergast |
| K202323 |
02/02/2021 |
Disposable Medical Surgical Masks |
Tianjin Teda Jinshan Easy Packing Manufacture Co., LTD |
Hui Liu |
| K212832 |
12/14/2021 |
TimeWaver Frequency |
TimeWaver Production GmbH |
Babak Jafarian |
| K203598 |
02/03/2021 |
Omnichroma Flow Bulk |
Tokuyama Dental Corporation |
Keith A. Baritt |
| K210223 |
12/15/2021 |
Transcutaneous Electrical Nerve Stimulator |
Top-Rank Health Care Co.,Ltd. |
James Zhou |
| K210102 |
12/17/2021 |
Topwide Surgical Face Mask |
Topwide (Hubei) Medical Products Manufacturer |
Shoucheng Zhang |
| K213580 |
12/03/2021 |
Adapter Sleeve for BIOLOX« OPTION Femoral Head, +10.5mm head length |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K203660 |
12/21/2021 |
TRI-matrix Implant Line |
TRI Dental Implants Int. AG |
Sandro Venanzoni |
| K210481 |
12/14/2021 |
Instant 20s Indicator |
True Indicating LLC |
Thomas Riha |
| K213547 |
12/23/2021 |
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla |
TTK Healthcare Limited |
Daniel J S |
| K213407 |
12/16/2021 |
UltiCare Disposable Pen Needles |
UltiMed Incorporated |
Paul Lewis |
| K211691 |
12/22/2021 |
Ultrast Gel |
Ultrast, Inc. |
Howard Levine |
| K210004 |
12/10/2021 |
i8 Tanning Booth |
Ultrasun International B.V. |
Tim Leusink |
| K213275 |
12/20/2021 |
EchoGo Core (2.0) |
Ultromics Limited |
Jaco Jacobs |
| K203539 |
12/10/2021 |
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) |
Unicoglobal, Inc. |
Yoonsok Park |
| K210147 |
12/22/2021 |
Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield |
Unicoglobal, Inc. |
Yoonsok Park |
| K201915 |
02/23/2021 |
GenesisZr 4Y+ (ST1100) Zirconia |
United Dental Resources Corporation |
John Von Thaden |
| K211624 |
12/18/2021 |
USA Gloves Nitrile Powder Free Exam Gloves |
USA Gloves |
Zishan Momin |
| K173738 |
02/26/2021 |
Archworx |
Utah Medical Products and Services |
Brandon Farley |
| K200932 |
12/14/2021 |
Blood Collection Needles |
Vacutest Kima Srl |
Monica Vianello |
| K203766 |
02/12/2021 |
4D Integrated Treatment Console |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K203307 |
02/17/2021 |
VIOLA |
Vascular Graft Solutions, Ltd. |
Orit Yarden |
| K203667 |
02/02/2021 |
EzRay M (Model: VMX-P300) |
Vatech Co., Ltd |
Daniel Kim |
| K210329 |
02/18/2021 |
Green X 18(Model : PHT-75CHS) |
Vatech Co., Ltd |
Daniel Kim |
| K200439 |
02/23/2021 |
Velano ExT Extension Set |
Velano Vascular |
Tiffini Wittwer |
| K212176 |
12/10/2021 |
CINtec Histology |
Ventana Medical Systems, Inc. |
Stacci Cronk |
| K202346 |
02/19/2021 |
SPiN Vision Video Bronchoscope System |
Veran Medical Technologies, Inc. |
B. Nathan Hunt |
| K212958 |
12/14/2021 |
MRIdian Linac System |
ViewRay, Incorporated |
Sean Delaney |
| K213149 |
12/09/2021 |
VOCO Retraction Paste |
Voco GmbH |
M Th Plaumann |
| K202219 |
02/11/2021 |
VORTRAN GO2VENT with PEEP Valve |
Vortran Medical Technology 1, Inc. |
Adam Palumbo |
| K212715 |
12/20/2021 |
Vy Spine ClariVy Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K213394 |
12/10/2021 |
Vy SpineÖ VySpanÖ PCT System |
Vy Spine, LLC |
Jordan Hendrickson |
| K213219 |
12/23/2021 |
Vy SpineÖ VyWasherÖ Buttress System |
Vy Spine, LLC |
Jordan Hendrickson |
| K213628 |
12/16/2021 |
VBrain |
Vysioneer Inc. |
Vicki Lin |
| K201703 |
02/24/2021 |
PROXEO Twist Cordless Polishing System PL-40 H |
W&H Dentalwerk Buermoos GmbH |
Johann Georg Scharl |
| K200368 |
02/05/2021 |
LINK Embrace Shoulder System - Reverse Configuration |
Waldemar Link GmbH & Co. KG |
Stephanie Fuchs |
| K210355 |
12/16/2021 |
Surgical Gown, Model: surgical gown-hp-3 |
Weihai Dishang Medical Technology Co., Ltd |
Ricky Xia |
| K213029 |
12/14/2021 |
Nitrile Examination Gloves (Powder free, Blue) |
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
Dong Bin |
| K212807 |
12/03/2021 |
Surgical Masks |
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
Bin Dong |
| K201868 |
02/22/2021 |
Phyziofit Medical Surgical Mask |
Wellpower Sporting Goods Co., Ltd |
Carol Tseng |
| K203343 |
12/21/2021 |
Wesper Lab |
Wesper Inc. |
Amir Reuveny |
| K203399 |
02/17/2021 |
FITBONE(R) TAA |
WITTENSTEIN intens GmbH |
Hartmut Kampa |
| K212861 |
12/15/2021 |
Surgical Gown, Reinforced Surgical Gown |
Wuhan Zonsen Medical Products Co.,Ltd |
Cynthia Ye |
| K192568 |
02/03/2021 |
Jaijian Self-Adhesive Electrode |
Wuxi Jiajian Medical Instrument Co., Ltd |
Caihong Sun |
| K213456 |
12/21/2021 |
Xenco Medical Multilevel CerviKit |
Xenco Medical, LLC |
Jason Haider |
| K212574 |
12/14/2021 |
Surgical Face Mask |
Xiantao Deming Healthcare products Co., Ltd |
Gan Jing |
| K212578 |
12/02/2021 |
Nitrile disposable examination gloves |
Xingyu Medical Tech Co., Ltd. |
Cathrine Luan |
| K203702 |
02/12/2021 |
Vinyl Examination Gloves (Yellow) |
Xinying Trading CO., LTD. |
Tongguang Liu |
| K213051 |
12/18/2021 |
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Yunnan Huazhiyuan Medical Technology Co., Ltd. |
Yun Gao |
| K211803 |
12/15/2021 |
HealthPPT |
Zebra Medical Vision Ltd. |
Shlomit Cymbalista |
| K211755 |
12/01/2021 |
Electric Breast Pump |
Zhejiang Carebao Co., Ltd. |
Yan Xie |
| K202823 |
12/15/2021 |
Innomed NPWT Silicone Foam Dressing |
Zhejiang Longterm Medical Technology Co., LTD |
Chloie Zsang |
| K212059 |
12/17/2021 |
Surgical Face Mask |
Zhongshan Saifute Labor Protective Articles CO., LTD |
Qionghua Ke |
| K203488 |
02/19/2021 |
emField |
Zimmer MedizinSysteme GmbH |
Ute Hauss |
| K210842 |
12/10/2021 |
VerSys Cemented Revision/Calcar |
Zimmer, Inc. |
Rhonda Myer |
| K200160 |
02/15/2021 |
740 SafeSAT |
Zoe Medical, Inc. |
Jim Chickering |
| K213031 |
12/20/2021 |
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console |
Zoll Circulation, Inc. |
Elizabeth Haines |
