| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K210277 |
03/03/2021 |
3M Attest Rapid Readout Biological Indicator, 1295 |
3M Company |
Mary Fretland |
| K210603 |
03/30/2021 |
3M Bair Hugger Temperature Management System (Model 675) |
3M Company |
Brian Kleiber |
| K203065 |
03/10/2021 |
Lumbar Spine Truss System Plating Solution (LSTS-PS) |
4Web, Inc. |
Jessee Hunt |
| K210555 |
03/23/2021 |
7D Surgical System - Drill Guide |
7D Surgical Inc. |
Daniel Zisind |
| K210043 |
03/03/2021 |
LOQTEQ Distal Lateral Femur Plate 4.5 System |
AAP Implantate AG |
Agnieszka Mierzejewska |
| K210392 |
03/11/2021 |
WorkMate Claris System |
Abbott |
Ed Sandberg |
| K210285 |
03/18/2021 |
Adaptable Ortho Innovations Intramedullary Nail System |
Adaptable Ortho Innovations, LLC |
Steve Palin |
| K203146 |
03/05/2021 |
Akesis Galaxy RTi |
Akesis Inc |
Christopher Brown |
| K203600 |
03/09/2021 |
VersaWrap |
Alafair Biosciences Inc |
Angela Mallery |
| K202411 |
03/10/2021 |
Surgical Mask |
Allmed Medical Products Co., Ltd. |
Vince Tian |
| K202409 |
03/09/2021 |
Surgical Mask |
Allmed Medical Products Co., Ltd. |
Vince Tian |
| K202879 |
03/03/2021 |
EOGas 4 Endo-SteriTest RRBI |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K202753 |
03/08/2021 |
iHealth Wireless No-Touch Forehead Thermometer |
Andon Health Co., Ltd. |
Liu Yi |
| K210266 |
03/02/2021 |
OverStitch Sx Endoscopic Suturing System |
Apollo Endosurgery Inc. |
David Hooper |
| K200502 |
03/31/2021 |
Myriad Particles |
Aroa Biosurgery Ltd. |
Tina O'Brien |
| K203834 |
03/25/2021 |
Arthrex Patella SuturePlates |
Arthrex Inc. |
Rebecca R. Homan |
| K203521 |
03/03/2021 |
FineCross M3 |
Ashitaka Factory of Terumo Corporation |
Vaibhav Sivaramakrishan |
| K210293 |
03/03/2021 |
AtriClip LAA Exclusion System |
AtriCure, Inc. |
Mary Galeano |
| K203614 |
03/11/2021 |
Monarch Bronchoscope |
Auris Health Inc., a Johnson and Johnson Family Company |
Somi Ekwealor |
| K210325 |
03/23/2021 |
APOLLO Anterior Cervical Plate (ACP) System |
Aurora Spine, Inc. |
Laszlo Garamszegi |
| K201533 |
03/01/2021 |
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes |
AVINENT Implant System S.L.U. |
Anna Cortina |
| K210631 |
03/31/2021 |
Avitus(r) Bone Harvester |
Avitus Orthopaedics, Inc. |
Maxim Budyansky |
| K201866 |
03/10/2021 |
NovaLine Tubing Sets for Hemodialysis |
Bain Medical Equipment(Guangzhou) Co., Ltd. |
Zoe Zeng |
| K203193 |
03/04/2021 |
BD Intraosseous Infusion System |
Bard Access Systems, Inc(BAS)[Wholly-owned subsidiary of BD] |
Connor Dahl |
| K201809 |
03/10/2021 |
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory |
Baxter Healthcare Corportation |
Kristen Bozzelli |
| K203425 |
03/05/2021 |
Surgical Mask |
BDC Dental Corporation Ltd. |
Lifang Zhang |
| K203086 |
03/02/2021 |
X-PLO2R |
Belluscura LLC |
Sarah Clark |
| K201492 |
03/10/2021 |
Non-Sterile Zirconia Block |
Bioden Co., Ltd |
MyeongEun Song |
| DEN200031 |
03/17/2021 |
BioFire Respiratory Panel 2.1 (RP2.1) |
Biofire Diagnostics, LLC |
Kristen J Kanack |
| K203252 |
03/16/2021 |
Multi-unit Abutments for CONELOG |
BioHorizons Implant Systems, Inc. |
Bill Hornbuckle |
| K201879 |
03/31/2021 |
Digital Thermometer Model T103, T104 |
Bioland Technology Ltd. |
Yiqing Feng |
| K210006 |
03/04/2021 |
MI DeTACH |
Biorep Technologies, Inc |
Victoria Enjamio |
| K202824 |
03/25/2021 |
BRS Procedure Face Mask |
Blackbriar Regulatory Services, LLC |
Vincent Angelico |
| K203697 |
03/12/2021 |
BC Reflex Uni Knee System |
Bodycad Laboratories, Inc. |
Nadine Adia |
| K203679 |
03/18/2021 |
Automatic Registration |
Brainlab AG |
Chiara Cunico |
| K202443 |
03/11/2021 |
Smart Kit Basic, Smart Kit Pro |
BSL Co., Ltd |
Jun Seok Lee |
| K201452 |
03/12/2021 |
Groshong NXT PICC Catheter |
C.R. Bard, Inc. |
Matthew Lyman |
| K203275 |
03/01/2021 |
Recon Support Catheter |
C.R. Bard, Inc. |
Andrew Quach |
| K203225 |
03/24/2021 |
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System |
Canon Medical Systems Corporation |
Paul Biggins |
| K210164 |
03/10/2021 |
Vantage Elan 1.5T, MRT-2020, V6.0 |
Canon Medical Systems Corporation |
Janine F. Reyes |
| K203323 |
03/04/2021 |
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F. Reyes |
| K202751 |
03/26/2021 |
TandemHeart Pump and Escort Controller |
CardiacAssist, Inc. |
Megan Walsh |
| K210282 |
03/03/2021 |
WIRION Embolic Protection System |
Cardiovascular Systems Inc. |
Erika Huffman |
| K210324 |
03/04/2021 |
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 |
CareFusion 2200 Inc |
Jane Weber |
| K202125 |
03/07/2021 |
Century Perfusion System |
Century HLM, LLC |
Jeff Poland |
| K202937 |
03/18/2021 |
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 |
Ceragem Co, Ltd. |
Hyeonggeun Hwang |
| K202113 |
03/02/2021 |
Ceragem Automatic Thermal Massager, Model CGM-MB-1901 |
Ceragem Co, Ltd. |
Hyeonggeun Hwang |
| K203836 |
03/30/2021 |
BOMEDENT Apex locator, WISMY Apex locator |
ChangZhou BoMedent Medical Technology Co., Ltd |
Zhang Lili |
| K210181 |
03/09/2021 |
Nordiwell Surgical Face Mask |
Changzhou Combat Protective Equipment Co., Ltd. |
Yanmei Song |
| K201634 |
03/26/2021 |
RG 3ml Medication Cartridge |
Chengdu Shifeng Medical Technology Co., Ltd. |
Nick Wang |
| K201965 |
03/02/2021 |
SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System |
Chison Medical Technologies Co., Ltd. |
Qifei Liu |
| K200925 |
03/18/2021 |
Clarus Peel-Away Introducer Sheath |
Clarus Medical, LLC |
Mark F. Brown |
| K203394 |
03/02/2021 |
PleuraFlow System with FlowGlide |
ClearFlow, Inc, |
Serrah Namini |
| K201466 |
03/26/2021 |
Tranberg CLS Laser Applicator |
Clinical Laserthermia Systems, AB |
Lars-Erik Eriksson |
| K202917 |
03/23/2021 |
LigaSure Exact Dissector, Nano-coated |
Covidien llc |
Nancy Sauer |
| K201581 |
03/06/2021 |
CPR BAND |
CREDO |
Ji Hyo Wang |
| K210226 |
03/30/2021 |
PicoSure Workstation |
Cynosure LLC |
Michael King |
| K203417 |
03/28/2021 |
DVT-4000S |
Daesung Maref CO., LTD. |
Su Hyeon So |
| K202773 |
03/18/2021 |
s-Clean SQ-SL Implant System Mini |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K210333 |
03/25/2021 |
DiaPaste |
Diadent Group International |
Kab Sun Lee |
| K210193 |
03/15/2021 |
DB-Composite |
Dimensional Bioceramics, LLC |
Duran N. Yetkinliner |
| K210828 |
03/23/2021 |
DIOnavi-Denture02 |
DIO Corporation |
Ji-Ae Park |
| K201508 |
03/09/2021 |
Infrared Thermometer |
Dongguan Prestige Sporting Goods Co., Ltd |
Zhang Zhao |
| K202591 |
03/09/2021 |
Body Infrared Thermometer HT-820D |
Dongguan Xintai Instrument Co., Ltd. |
Wei Wang |
| K203116 |
03/19/2021 |
SensorX |
Durr Dental SE |
Oliver Lange |
| K203273 |
03/25/2021 |
FibroScan« Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) |
Echosens |
Karine Bonenfant |
| K210308 |
03/30/2021 |
EMPOWR Porous Femur with HAnano SurfaceTM |
Encore Medical, L.P. |
Christine Chesnutt |
| K203641 |
03/30/2021 |
E-Denture Pro |
EnvisionTEC GmbH |
Ruediger van Bernum |
| K203133 |
03/24/2021 |
ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube |
ENvizion Medical Ltd. |
Doron Besser |
| K201626 |
03/24/2021 |
Safety Subcutaneous Infusion Set |
Epic Medical Pte. Ltd. |
Freddie Lee |
| K203827 |
03/29/2021 |
REMI |
Epitel, Inc. |
Mark Lehmkuhle |
| K202693 |
03/05/2021 |
NeoWave Pain Relief and Recovery System, Model# T16-2020 |
Eva Medtec, Inc |
Irene Waldridge |
| K192731 |
03/19/2021 |
ZIDA Wearable Neuromodulation System |
Exodus Innovations |
Isaac Oppenheim |
| K201892 |
03/11/2021 |
Ritleng«+ and Ritleng«+ PVP |
FCI (France Chirurgie Instrumentation) SAS |
Thierry Fetick |
| K210225 |
03/04/2021 |
Surgical Face Mask |
Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd |
Qiyuan Ning |
| DEN200022 |
03/01/2021 |
Analytic for Hemodynamic Instability (AHI) |
Fifth Eye Inc. |
Jennifer A Baird |
| K203703 |
03/24/2021 |
I-Q View |
First Source, Inc. |
Susan Ryan-Kron |
| K201723 |
03/16/2021 |
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling |
Fisher & Paykel Healthcare Ltd. |
Reena Daken |
| K192649 |
03/12/2021 |
Endo Motor |
Foshan CICADA Dental Instrument Co., Ltd. |
Juan Liu |
| K201982 |
03/25/2021 |
Air compression therapy system FO-3001; Air compression therapy system FO-3008 |
Foshan Hongfeng Co., Ltd |
Cheng Dongfeng |
| K202424 |
03/31/2021 |
Surgical Mask-Models CR02-2, CR02 |
Foshan Xinbao Technology Co., Ltd. |
Weishan Peng |
| K202985 |
03/19/2021 |
LightWalker Laser System Family |
Fotona d.o.o. |
Pucer Anja |
| K202214 |
03/02/2021 |
IFM Surgical Mask Model SM3 |
FSSC, LLC |
Clayton Geyer |
| K202838 |
03/05/2021 |
Andorate Universal Endoscope Tip Guard |
GA Health Company Limited |
Cindy Ye |
| K210173 |
03/29/2021 |
StarGuide |
GE Healthcare |
George Mashour |
| K202658 |
03/05/2021 |
Vivid E80/ Vivid E90/ Vivid E95 |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K203617 |
03/02/2021 |
MaxFOV 2 |
GE Medical Systems, LLC. |
Amy Yang |
| K203346 |
03/05/2021 |
OEC 3D |
GE OEC Medical Systems, Inc. |
Kenny M. Bello |
| K210280 |
03/03/2021 |
Geistlich Mucograft«, Geistlich Mucograft« Seal |
Geistlich Pharma AG |
Marco Steiner |
| K201728 |
03/08/2021 |
Versalock Periprosthetic Femur Plates System-GMReis |
GM dos Reis Industria e Comercio Ltda |
Paula Oliveira |
| K203054 |
03/05/2021 |
FlexSys |
GME German Medical Engineering GmbH |
Stefan Schulze |
| K201410 |
03/12/2021 |
VENUS Bracket, ROSE Bracket |
GNI Co., LTD |
Duk Soo Kim |
| K203296 |
03/22/2021 |
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit |
Gold Standard Diagnostics |
Napoleon Monce |
| K203292 |
03/22/2021 |
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit |
Gold Standard Diagnostics |
Napoleon Monce |
| K203295 |
03/22/2021 |
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit |
Gold Standard Diagnostics |
Napoleon Monce |
| K203289 |
03/22/2021 |
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit |
Gold Standard Diagnostics |
Napoleon Monce |
| K210534 |
03/26/2021 |
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System |
Gramercy Extremity Orthopedics, LLC |
Michael P. Simpson |
| K210058 |
03/30/2021 |
Blue Nitrile Exam Glove, Powder Free |
Great Harvest Trading Co., Ltd. |
Chongfeng Zhao |
| K200601 |
03/29/2021 |
LumiCare Caries Diagnostic Rinse |
GreenMark Biomedical Inc. |
Steven Bloembergen |
| K203593 |
03/19/2021 |
Patient Examination Gloves |
Guang Dong Kingfa SCI. & TECH.CO., LTD. |
Xiaoge Yu |
| K201974 |
03/07/2021 |
Single-use medical face mask |
Guangdong Horigen Mother & Baby Products Co., Ltd |
Jun Deng |
| K202891 |
03/09/2021 |
Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Endless Chan |
| K202650 |
03/24/2021 |
Medical disposable face mask non sterile |
Guangdong Zhong Ling Industrial Group Co., Ltd. |
Ann Ho |
| K203188 |
03/12/2021 |
ADD |
H&abyz Co., Ltd. |
Namkyu Hur |
| K202316 |
03/03/2021 |
Medical mask (Model: KKF-1A) |
Han Zhaoqing Sporting Goods Company Limited |
Zhang Ming |
| K201698 |
03/15/2021 |
Medical Surgical Mask |
Hangzhou Mycode Bio-Medicine Co., Ltd. |
Alice Gong |
| K202133 |
03/25/2021 |
Disposable Medical Mask |
Hangzhou Qianzhiya Sanitary Products Co., Ltd |
Yu Shao |
| DEN200050 |
03/26/2021 |
Portable Neuromodulation Stimulator (PoNS) |
Helius Medical, Inc. |
Lawrence Picciano |
| K202018 |
03/04/2021 |
Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation |
Hill-Rom, Inc. |
Jigar Shah |
| K203574 |
03/10/2021 |
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 |
Hivox Biotek Inc. |
Ruby Lu |
| K201095 |
03/19/2021 |
Sovereign America Surgical Face Mask |
HomTex, Inc. |
Jeremy Wootten |
| K201852 |
03/02/2021 |
Surgical Mask-Model Number: Ear Loop, Flat-Pleated |
Huizhou Foryou Medical Devices Co., Ltd |
Guosheng Tan |
| K202161 |
03/10/2021 |
Surgical Face Mask |
Hunan EEXI Technology & Service Co., Ltd. |
Zhang Xianliang |
| K202439 |
03/08/2021 |
Disposable Medical Face Mask |
Hunan EEXI Technology & Service Co.,Ltd. |
Zhang Xianliang |
| K210487 |
03/16/2021 |
MIPLNI YK-244 Disposable Surgical Mask |
Hunan Yuankang Biological Technology Co., Ltd |
Kylin Rui Chen |
| K203822 |
03/12/2021 |
ProFound AI Software V3.0 |
iCAD Inc. |
Heather Reed |
| K201678 |
03/08/2021 |
iCE-SG Subcutaneous Electrode Arrays |
iCE Neurosystems, Inc. |
Allen Waziri |
| K202037 |
03/01/2021 |
imani i2 |
imani Co. |
Hyo-Soon Hwang |
| K203256 |
03/09/2021 |
Imbio RV/LV Software |
Imbio, LLC |
William McLain |
| K210110 |
03/31/2021 |
Guidion |
IMDS Operations B.V. |
Edwin Schulting |
| K203612 |
03/22/2021 |
Capture-CMV |
Immucor, Inc. |
Steven Appel |
| K203764 |
03/03/2021 |
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform |
Imperative Care Inc. |
Kristin Ellis |
| K210060 |
03/12/2021 |
CoLink Mfx Implant System |
In2Bones USA, LLC |
Christine Scifert |
| K201285 |
03/05/2021 |
InMode Evolve System with the Tone Applicator |
InMode Ltd. |
Amit Goren |
| K203261 |
03/05/2021 |
Reprocessed Inquiry Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
Rick Ferreira |
| K201681 |
03/18/2021 |
Straumann Immediate Temporary Abutments |
Institut Straumann AG |
Viviana Horhoiu |
| K202708 |
03/30/2021 |
Surgical Face Masks |
Intco Medical(HK) Co., Ltd. |
Max Li |
| K203038 |
03/26/2021 |
Toro-L Interbody Fusion System |
Integrity Implants Inc |
Lauren Kamer |
| K193663 |
03/10/2021 |
FloPump 57mL Centrifugal Pump |
International Biophysics Corporation |
Geoff Marcek |
| K202379 |
03/19/2021 |
Invacare AVIVA Storm RX Power Chair |
Invacare Corporation |
Elijah Wreh |
| K201896 |
03/30/2021 |
ivi N3003 Surgical face Mask, ivi N6006 Surgical mask |
IOB Medical Inc |
Jiulin Xia |
| K210316 |
03/03/2021 |
Mars 1417X Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K210314 |
03/02/2021 |
Mars1717X Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K203653 |
03/02/2021 |
MRI PPG Patient Cable |
Ivy Biomedical Systems, Inc. |
Alejandra Aceves |
| K202905 |
03/26/2021 |
Disposable Face Mask |
Jiangsu Excellence Medical Supplies Co., Ltd |
Jing Zhu |
| K202482 |
03/18/2021 |
Y207 Electric Wheelchair |
Jiangsu Intco Medical Products Co., Ltd. |
Wang Maokun |
| K202205 |
03/09/2021 |
Surgical Face Mask |
Jiangsu Micsafe Medical Technology Co., Ltd |
Tony Yang |
| K202402 |
03/01/2021 |
Nitrile Examination Gloves (Blue, Violet Blue, White) |
Jiangsu Tianshuo Medical Products Co., Ltd. |
Gao Feng |
| K203618 |
03/09/2021 |
Neodent EasyGuide Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Camila da Silva Esteves |
| K203382 |
03/15/2021 |
Neodent Implant System-Easy Pack |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K202889 |
03/02/2021 |
Able Medical Devices Valkyrie Thoracic Fixation System |
JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices |
Wade DePas |
| K203060 |
03/12/2021 |
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control |
Johnson & Johnson Surgical Vision, Inc. |
Amanda Houston |
| K210638 |
03/26/2021 |
i-ED COIL System |
Kaneka Medical America LLC |
Audra Bogucki |
| K202356 |
03/02/2021 |
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) |
Kanglongda Vietnam Protection Technology Company Limited |
Lu Lingfeng |
| K201001 |
03/30/2021 |
Modulith SLX-F2 |
KARL STORZ Endoscopy America |
Winkie Wong |
| K203361 |
03/17/2021 |
ProLift Wedge Expandable Spacer System |
Life Spine, Inc. |
Angela Batker |
| K210616 |
03/31/2021 |
Longeviti PMMA Static Cranial Implant |
Longeviti Neuro Solutions, LLC |
Heather Hourihan |
| K203666 |
03/12/2021 |
Vinyl Examination Gloves(Yellow) |
Lutai Medical Technology Co.,LTD. |
Xiaomeng Xiaomeng Li |
| K203788 |
03/26/2021 |
DermaV Laser System |
Lutronic Corporation |
Jhung Won Vojir |
| K203083 |
03/17/2021 |
Magic 360 Power Wheelchair |
Magic Mobility |
Alex Suen |
| K203684 |
03/17/2021 |
Neurosign V4 Intraoperative Nerve Monitor |
Magstim Company Ltd. |
Rosie Hunt |
| K201927 |
03/01/2021 |
Getinge GSS610N Series Steam Sterilizer |
Maquet GmbH |
Holger Ullrich |
| K202015 |
03/24/2021 |
White ENDOSEAL MTA |
Maruchi |
Sung Wook Jang |
| K201590 |
03/29/2021 |
EMMA Capnograph |
Masimo Corporation |
Katelynn Kirby |
| K191441 |
03/05/2021 |
Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) |
Maxstar Industrial Co., Ltd. |
Jonghwa Lim |
| K203259 |
03/26/2021 |
FairFix Adjustable Button System |
Medacta International SA |
Stefano Baj |
| K210010 |
03/02/2021 |
GMK Revision & Hinge Extension - TiNbN Coating |
Medacta International SA |
Stefano Baj |
| K210207 |
03/26/2021 |
Humeral Eccentric Reverse Metaphysis |
Medacta International SA |
Stefano Baj |
| K203755 |
03/02/2021 |
Shoulder System - TiNbN Coating |
Medacta International SA |
Stefano Baj |
| K210286 |
03/18/2021 |
Cure 2.0 Anterior Cervical Plate (ACP) System |
Meditech Spine, LLC |
Bruce Dunaway |
| K210526 |
03/12/2021 |
Medline Cautery Tip Cleaner |
Medline Industries, Inc. |
Matt Clausen |
| K203186 |
03/18/2021 |
DYNATAPE Suture |
Medos International SARL |
Tatyana Korsunsky |
| K210449 |
03/18/2021 |
InfinityÖ OCT System, PASS OCT« Spinal System |
Medtronic |
Shweta Sharma |
| K202913 |
03/05/2021 |
NeuroCap (Model DEC22) |
Memory MD Inc |
Boris Goldstein |
| K203606 |
03/10/2021 |
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) |
Meris Investment Group |
Gary Maas |
| K201674 |
03/03/2021 |
Cultura Collection and Transport System |
Merit Medical Systems, Inc |
Alex Bohorquez |
| K203358 |
03/01/2021 |
Solitaire X Revascularization Device |
Micro Therapeutics, Inc d/b/a ev3 Neurovascular |
Kevin Kong |
| K202438 |
03/15/2021 |
Ensure Single-Use Coagulation Forceps |
Micro-Tech (Nanjing) Co., Ltd. |
Cecilia Sun |
| K201975 |
03/11/2021 |
miha bodytec II |
Miha Bodytec Gmbh |
Felix Schweigert |
| K210479 |
03/19/2021 |
IMPACT and X-Ranger |
MinXray, Inc. |
Keith Kretchmer |
| K202483 |
03/23/2021 |
MyHomeDoc |
MyHomeDoc Ltd. |
Orly Maor |
| K203547 |
03/25/2021 |
Nalu Neurostimulation System |
Nalu Medical, Inc. |
Pauline Lieu |
| K201734 |
03/26/2021 |
AllerBlock Junior |
Nasaleze International Ltd |
Matt Duxbury |
| K202073 |
03/25/2021 |
NeedleSmart Professional (NS Pro) |
NeedleSmart Limited |
Tom Baker |
| K203444 |
03/18/2021 |
BEE HA Cage |
NGMedical GmbH |
Stella Hahn |
| K202944 |
03/25/2021 |
NEBULAE SRS Laparoscopic Surgical Smoke Removal System |
Northgate Technologies Inc. |
Todd Gatto |
| K210271 |
03/01/2021 |
NuVasive Modulus ALIF System |
NuVasive, Incorporated |
Jessica LeBlanc |
| K201775 |
03/05/2021 |
NuVision ICE Catheter |
NuVera Medical, Inc. |
Robert Nardelli |
| K203518 |
03/09/2021 |
Quicktome |
Omniscient Neurotechnology Pty Ltd (o8t) |
Arie Henkin |
| K202284 |
03/12/2021 |
Oncospace |
Oncospace, Inc. |
Praveen Sinha |
| K202300 |
03/05/2021 |
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform |
Optellum Ltd |
David Arrowsmith |
| K203737 |
03/22/2021 |
Spark Clear Aligner System |
Ormco Corporation |
Frank Ray |
| K203342 |
03/18/2021 |
CONSTRUX Mini Ti Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K210667 |
03/25/2021 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
Jacki Koch |
| K203576 |
03/03/2021 |
FORZA Ti Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K210125 |
03/19/2021 |
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta |
OSARTIS GmbH |
Volker Stirnal |
| K210120 |
03/19/2021 |
BonOs HV, BonOs MV, BonOs LV |
Osartis GmbH |
Volker Stirnal |
| K210041 |
03/18/2021 |
HySil Plus Impression Materials |
Osstem Implant Co., Ltd. |
Jinwoo Bae |
| K203807 |
03/03/2021 |
Ponto Bone Anchored Hearing System, MONO Surgery Kit |
Oticon Medical AB |
Carolina Anker Wessling |
| K201426 |
03/26/2021 |
MyCRO Band |
Otto Bock Healthcare LP |
Caleb Beck |
| K203250 |
03/12/2021 |
TaiChiC |
Our United Corporation |
Qi Liu |
| DEN200019 |
03/26/2021 |
Oxehealth Vital Signs |
Oxehealth Limited |
Hugh Lloyd-Jukes |
| K210390 |
03/06/2021 |
Apex 3D Total Ankle Replacement System |
Paragon 28, Inc. |
Haylie Hertz |
| K203064 |
03/23/2021 |
ICU Health Surgical Mask |
Plastikon Industries |
Paul Gutwald |
| K210450 |
03/17/2021 |
BBX-PET Scanner |
Prescient Imaging, LLC |
Farhad Daghighian |
| K210328 |
03/05/2021 |
SafeSept Blunt Needle |
Pressure Products Medical Device Manufacturing LLC |
Andrew Amour |
| K203505 |
03/29/2021 |
DORO QR3 Headrest System (Aluminum) |
pro med instruments GmbH |
Muhammad Zubair |
| K202961 |
03/11/2021 |
AquaBeam Robotic System |
PROCEPT BioRobotics Corporation |
Sara Muddell |
| K202518 |
03/03/2021 |
Promaxo MRI System |
Promaxo, Inc. |
Eva Hellman |
| K202628 |
03/19/2021 |
Disposable Medical Face Mask |
Qinghai Zhong Dao Win-win Medical Protective Equipment Co., |
Zhaochu Chen |
| K201924 |
03/15/2021 |
Single-Use Surgical Mask |
Qiqihar Hengxin Medical Supplies, Ltd. |
Sihui Xiong |
| K210142 |
03/11/2021 |
Fiber Dust |
Quanta System Spa |
Francesco Dell'Antonio |
| K203592 |
03/23/2021 |
Tigertriever and Tigertriever 17 Revascularization Devce |
Rapid Medical Ltd. |
Orit Yaniv |
| K210057 |
03/31/2021 |
Blue Nitrile Exam Glove, Powder Free |
Real Star Medical Technology Co., Ltd. |
Nie Jian |
| K203052 |
03/21/2021 |
Movement and Compressions System (the MAC System) |
Recovery Force, LLC |
Jeff Schwegman |
| K201420 |
03/05/2021 |
Republic Spine Dark Star Spinal System |
Republic Spine, LLC |
James Doulgeris |
| K203378 |
03/31/2021 |
Pulsehaler |
Respinova Ltd. |
Cliff Ansel |
| K202062 |
03/11/2021 |
wheezo WheezeRate Detector |
Respiri Limited |
Samaneh Sarraf |
| K202453 |
03/24/2021 |
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card |
Safecare Biotech(Hangzhou)Co.,Ltd. |
Alex Qiu |
| K201617 |
03/12/2021 |
TipVision Videoscope System (TipVision VideoScope 0░/30░; EleVision HD 2 Camera Control Unit (CCU)) |
Schoelly Fiberoptic GmbH |
Sandra Baumann |
| K203101 |
03/31/2021 |
Secure Wear USA Surgical Face Mask |
Secured Ortho Manufacturing of America, LLC |
Vincent Benenati |
| K210654 |
03/31/2021 |
EnCor Breast Biopsy Probe with Rinse Tube |
SenoRx, Inc. |
Jessica Myer |
| K202081 |
03/19/2021 |
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue |
Shen Wei USA Inc. |
Cheryl Reep |
| K202076 |
03/05/2021 |
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors |
Shen Wei USA Inc. |
Cheryl Reep |
| K202083 |
03/25/2021 |
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs |
Shen Wei USA Inc. |
Cheryl Reep |
| K202082 |
03/17/2021 |
Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid |
Shen Wei USA Inc. |
Cheryl Reep |
| K202086 |
03/16/2021 |
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors |
Shen Wei USA Inc. |
Cheryl Reep |
| K202080 |
03/24/2021 |
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color |
Shen Wei USA Inc. |
Cheryl Reep |
| K202078 |
03/05/2021 |
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove |
Shen Wei USA Inc. |
Cheryl Reep |
| K202009 |
03/22/2021 |
Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 |
Shenzhen Juzhong Technology Co., Ltd |
Chang Lihua |
| K200177 |
03/25/2021 |
Low-frequency Multi-function physiotherapy instrument |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K202776 |
03/01/2021 |
Fingertip pulse oximeter |
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. |
Aaron Lin |
| K202743 |
03/01/2021 |
Med-Link Temp-pulse Oximeter |
Shenzhen Med-link Electronics Tech Co., Ltd |
Jialing Zhang |
| K203391 |
03/23/2021 |
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Ma Chao |
| K201957 |
03/26/2021 |
A8, A9 Anesthesia System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
Yanhong Bai |
| K203707 |
03/12/2021 |
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 |
ShenZhen ZhengKang Technology Co., Ltd. |
Huayong Yang |
| K203258 |
03/31/2021 |
syngo.CT Lung CAD |
Siemens Healthcare GmbH |
Abhineet Johri |
| K210262 |
03/03/2021 |
Biograph Vision Quadra PET/CT System |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K210309 |
03/05/2021 |
Cios Select (VA21) Flat Panel |
Siemens Medical Solutions USA, Inc. |
Cordell Fields |
| K210307 |
03/04/2021 |
Cios Select (VA21) Image Intensifier |
Siemens Medical Solutions USA, Inc. |
Cordell Fields |
| K203443 |
03/31/2021 |
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea |
Siemens Medical Solutions USA, Inc. |
Andrew Turner |
| K202678 |
03/01/2021 |
OMNI Surgical System |
Sight Sciences, Inc. |
Edward J. Sinclair |
| K210566 |
03/25/2021 |
LEGION Porous CR Narrow Femoral Components |
Smith & Nephew, Inc. |
Michelle Huettner |
| K201921 |
03/26/2021 |
Spacelabs Lifescreen PRO Analyzer |
Spacelabs Healthcare Ltd. |
Roger Moldon |
| K203254 |
03/26/2021 |
Lucent 3D Spinal System |
Spinal Elements, Inc. |
Julie Lamothe |
| K210472 |
03/19/2021 |
SPINEART Navigation Instrument System |
Spineart |
Franck Pennesi |
| K210359 |
03/10/2021 |
Hexanium TLIF |
SpineVision SAS |
Arnaud Brisard |
| K201624 |
03/18/2021 |
Spin Care Disposable Protective Mask |
SpinTech LLC |
Jim Jean |
| K203780 |
03/23/2021 |
Harvester SI: Sacroiliac Fixation System |
Spinus International, Inc. |
Ron Oman |
| K203776 |
03/25/2021 |
Surgical Masks, Model SNN200640 & MN112 |
SQ Medical Supplies Inc. |
Jonathan Lim |
| K210584 |
03/18/2021 |
SDC3 HD Information Management System with Wireless Device Control Capability |
Stryker |
Divya Sekar |
| K210078 |
03/11/2021 |
Stryker ProCinch Adjustable Loop Device |
Stryker Endoscopy |
Victoria Milich |
| K203205 |
03/23/2021 |
Navigated Spine Instruments |
Stryker Spine |
Megan Callanan |
| K202554 |
03/16/2021 |
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis |
Stryker Sustainability Solutions |
Aphrodeja Crutch |
| K210071 |
03/31/2021 |
SIS System (Version 5.1.0) |
Surgical Information Sciences, Inc. |
Ann Quinlan-Smith |
| K202547 |
03/26/2021 |
Surgivisio system |
Surgivisio |
Vincent Lere |
| K210205 |
03/26/2021 |
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System |
Synthes (USA) products, LLC |
Satapa Dhamankar |
| K210498 |
03/24/2021 |
Betta Link Knotless Implant System |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K202492 |
03/22/2021 |
EZ-IO Intraosseous Vascular Access System |
Teleflex Medical |
Rachel Rehl |
| K203775 |
03/12/2021 |
AIC disposable medical mask |
The Aleen International Corporation |
Can Huang |
| K202725 |
03/26/2021 |
ETD4000 |
TheraSigma, LLC |
Jim Klett |
| DEN200006 |
03/05/2021 |
ClearUP Sinus Relief |
Tivic Health Systems Inc. |
Michael Nketiah |
| K203826 |
03/29/2021 |
LaserCap Family of Lasers 300, 224, 120 & 80 |
Transdermal Cap, Inc. |
Michael Rabin |
| K202166 |
03/02/2021 |
Senhance Surgical System |
TransEnterix, Inc. |
Kaitlyn Alexander |
| K201197 |
03/26/2021 |
TruAbutment DS, TruBase S |
TruAbutment Inc. |
Eunjin Jang |
| K202186 |
03/23/2021 |
TrueRelief Device |
TrueRelief |
John Crosson |
| K203560 |
03/24/2021 |
STERIZONE VP4 Test Pack |
TSO3 Inc., Now a part of Stryker |
Karan Modi |
| K202137 |
03/04/2021 |
Disposable medical mask |
U-Play Products Corporation |
Jin Jing |
| K210550 |
03/01/2021 |
VALO Grand Corded and Accessory Lenses |
Ultradent Products, Inc |
Adam Black |
| K210019 |
03/04/2021 |
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ |
Unimed Medical Supplies, Inc. |
Linbin Ye |
| K203351 |
03/08/2021 |
Perfit ZR HT Dental Zirconia blank |
Vatech acucera, Inc. |
Kyung Wook Kwon |
| K203387 |
03/04/2021 |
AlignRT Plus |
Vision RT Ltd |
Jade Dunphy |
| K201376 |
03/25/2021 |
ANAM Test System |
Vista LifeSciences, Inc. |
Margaret E. Molloy |
| K210209 |
03/23/2021 |
Viz ICH |
Viz.ai, Inc. |
Gregory Ramina |
| K203235 |
03/19/2021 |
VBrain |
Vysioneer Inc. |
Jen-Tang Lu |
| K202710 |
03/09/2021 |
Disposable Medical Face Mask |
Wanxinda (Guangzhou) Technology Product Co., Ltd |
Zeng Xueping |
| K202548 |
03/10/2021 |
Surgical Face Mask |
Wanxinda (Guangzhou) Technology Product Co., Ltd |
Zeng Xueping |
| K200660 |
03/08/2021 |
Compressible Limb and Circulation Therapy System |
Wonjin Mulsan Co., Ltd |
Ha Yong Jung |
| K202815 |
03/10/2021 |
PROPHECY Preoperative Navigation Alignment System |
Wright Medical Technology, Inc. |
Paxia Her |
| K202191 |
03/29/2021 |
Surgical Mask |
Wuhan Zonsen Medical Products Co., Ltd |
Shirly Xi |
| K203620 |
03/23/2021 |
Aneroid Sphygmomanometer |
Wuxi Exanovo Medical Instrument Co., Ltd. |
Xiao Huang |
| K203685 |
03/26/2021 |
Disposable Surgical Face Mask |
Xiantao Zhongyi Safety & Protection Products Co., Ltd |
Yang Xi |
| K201422 |
03/02/2021 |
Arisure Closed System Drug Transfer Device (CSTD) |
Yukon Medical, LLC |
Pamela McNulty |
| K201878 |
03/25/2021 |
ST-Z5 |
Z-Systems AG |
Rubino DiGirolamo |
| K203428 |
03/17/2021 |
Ziehm Vision RFD |
Ziehm Imaging GmbH |
Stefan Fiedler |
| K210551 |
03/18/2021 |
Persona Revision Knee System |
Zimmer, Inc. |
Romil Sheth |
| K202375 |
03/09/2021 |
ZOLL Propaq M |
ZOLL Medical Corporation |
Elizabeth McMeniman |
