| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K202598 |
05/06/2021 |
3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Le |
3A Medical Products Co., Ltd |
Slinda Ma |
| K201671 |
05/04/2021 |
A-Link Z |
Acuity Surgical Devices, LLC |
Bryan Cowan |
| K211100 |
05/14/2021 |
AcQGuide MAX Steerable Sheath |
Acutus Medical, Inc. |
Serena Sanginthirath |
| K210974 |
05/12/2021 |
High Performance Antimicrobial Gelling Fiber with Silver |
Advanced Medical Solutions Ltd. |
Kay McGrath |
| K203749 |
05/03/2021 |
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable |
Ambu A/S |
Karina Matthiesen |
| K201504 |
05/10/2021 |
Single-use medical poly (vinyl chloride) examination glove |
Anhui Bytech Medical Supplies Co., Ltd. |
Cheng Wang |
| K210302 |
05/14/2021 |
Disposable Medical mask |
Anhui JBH Medical Apparatus Co., Ltd. |
Dandan Yang |
| K210917 |
05/28/2021 |
Single Use Injection Needle |
Anrei Medical (Hangzhou) Co., Ltd. |
Huibing Yang |
| K203192 |
05/04/2021 |
NaviCam Xpress Stomach System |
AnX Robotica Corp |
Shoshana (Shosh) Friedman |
| K211282 |
05/27/2021 |
Aqua Medical RF Vapor System |
Aqua Medical, Inc. |
Lloyd Mencinger |
| K211311 |
05/28/2021 |
AtriCure Isolator« SynergyÖ Surgical Ablation System |
AtriCure, Inc. |
Jon McElwee |
| K210237 |
05/19/2021 |
CINA CHEST |
Avicenna.AI |
Stephane Berger |
| K202932 |
05/28/2021 |
ABT12 multi-purpose solution |
Bausch & Lomb Incorporated |
Melissa Thomas |
| K210975 |
05/24/2021 |
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia |
Bausch & Lomb Incorporated |
Barbara Klube-Falso |
| K202423 |
05/18/2021 |
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 ╡g/mL) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K201639 |
05/27/2021 |
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads |
Beijing Biosis Healing Biological Technology Co., Ltd. |
Ting Jiang |
| K210168 |
05/10/2021 |
Diode Laser Therapy Systems |
Beijing Kes Biology Technology CO., LTD. |
Wei Meng Meng |
| K211034 |
05/06/2021 |
Corvus Radiation Therapy Planning System |
Best Nomos |
Vineet Gupta |
| K202145 |
05/07/2021 |
Bigfoot Unity Diabetes Management System |
Bigfoot Biomedical, Inc. |
Kate Lee |
| K210417 |
05/14/2021 |
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL |
Bio Compression Systems, Inc. |
Marc Somelofski |
| K210815 |
05/13/2021 |
Disposable Face Mask |
Biobase Scientific (Shandong) Co., Ltd. |
Qingxiang Hou |
| K200765 |
05/05/2021 |
Genius / Genuin Total Knee System |
Biorad Medisys PVT LTD |
Sudhakar Saxena |
| K210289 |
05/28/2021 |
Infant Phototherapy Equipment |
Bistos Co., Ltd. |
Dae Eun Kim |
| K203640 |
05/06/2021 |
CoolSeal Reveal |
Bolder Surgical, LLC |
Nicholas Wong |
| K203183 |
05/06/2021 |
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) |
Bolder Surgical, LLC |
Nicholas Wong |
| K211008 |
05/05/2021 |
Bose SoundControl Hearing Aids |
Bose Corporation |
Bryn Kieras |
| K210353 |
05/06/2021 |
AutoCap RX |
Boston Scientific Corporation |
Kyra McNamara |
| K210608 |
05/25/2021 |
LUX-Dx Insertable Cardiac Monitor |
Boston Scientific Corporation |
Melissa Klamerus |
| K203322 |
05/26/2021 |
SpyGlass Discover Retrieval Basket |
Boston Scientific Corporation |
Lindsay Forys |
| K211037 |
05/17/2021 |
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Paul Biggins |
| K203450 |
05/04/2021 |
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) |
CapNostics, LLC |
Martin von Dyck |
| K211251 |
05/26/2021 |
ViperCath XC Peripheral Exchange Catheter |
Cardiovascular Systems, Inc. |
Erika Huffman |
| K202765 |
05/27/2021 |
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K203036 |
05/07/2021 |
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) |
Central Medicare Sdn Bhd |
Fatin Nor Irdina Bt Ahmad Fauzi |
| K202793 |
05/17/2021 |
Cercare Medical Neurosuite |
Cercare Medical ApS |
Mikkel Bo Hansen |
| K203331 |
05/20/2021 |
Quick-20m |
CGX, LLC |
Spencer Linton |
| K203311 |
05/10/2021 |
ChoiceSpine Blackhawk Ti Cervical Spacer System |
ChoiceSpine, LLC |
Kim Finch |
| K210306 |
05/19/2021 |
GII Spinal Fixation System |
Coligne AG |
Robert B Lange |
| K210191 |
05/06/2021 |
Identity Imprint Knee Replacement System |
Conformis Inc. |
Kara Johnson |
| K210809 |
05/12/2021 |
iTotal« IdentityÖ Cruciate Retaining (CR) Knee Replacement System (KRS) |
Conformis, Inc. |
Mary Kruitwagen |
| K202955 |
05/19/2021 |
Contour Light CL-100 |
Contour Research, LLC |
Doug Dreier |
| K210476 |
05/20/2021 |
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle |
Cook Ireland Ltd. |
Fay Dalton |
| K201569 |
05/19/2021 |
CUVIS-spine |
Curexo, Inc. |
Jungeun Park |
| K210705 |
05/06/2021 |
Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 |
Defender Safety Inc. |
Nahal Islam |
| K210581 |
05/20/2021 |
Actis DuoFix Hip Prosthesis- Collarless |
DePuy Ireland UC |
Elaine Pears |
| K211460 |
05/25/2021 |
Air Relax Plus Model AR-3.0 |
Diode Art Engineering doing business as Air Relax |
Beomjoon Lee |
| K190737 |
05/10/2021 |
Solax Electric Scooter (Models: S204311M, S204161, S204143) |
Dongguan Prestige Sporting Goods Co., Ltd. |
Zhang Zhao |
| K210394 |
05/19/2021 |
Electrosurgical accessory |
Dornier MedTech America Inc. |
John Hoffer |
| K203144 |
05/25/2021 |
MicroPen EVO |
Eclipse MedCorp, LLC |
Julie Summerville |
| K203687 |
05/28/2021 |
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index |
Edwards lifesciences, LLC |
Varad Raghuwanshi |
| K210977 |
05/25/2021 |
E-Dent 1000 |
EnvisionTEC GmbH |
Ruediger van Bernum |
| K211273 |
05/21/2021 |
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K211261 |
05/28/2021 |
Axis Charcot Fixation System |
Extremity Medical, LLC. |
Mary Hoffman |
| K203529 |
05/04/2021 |
VASSALLO GT Hybrid |
Filmecc Co., Ltd. |
Toshiya Osawa |
| K211312 |
05/21/2021 |
Universal Viewer |
GE Healthcare |
John Braam |
| K211118 |
05/13/2021 |
SIGNA 7.0T |
GE Medical Systems, LLC |
Brian R. Zielski |
| K201936 |
05/06/2021 |
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL |
Gilero, LLC |
Kristin Benokraitis |
| K201152 |
05/04/2021 |
Electric Breast Pump |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
Jun Deng |
| K211130 |
05/14/2021 |
NPseal |
Guard Medical Inc. |
Machiel Van Der Leest |
| K203320 |
05/10/2021 |
Endo Motor |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Alex Wang |
| K201697 |
05/06/2021 |
Umbilical Vessels Catheter |
Haolang Medical USA Corporation |
Lisa Xu |
| K193649 |
05/10/2021 |
Yumizen C1200 Creatinine PAP |
Horiba ABX SAS |
Caroline Ferrer |
| K210572 |
05/11/2021 |
Neurodyn V2.0, Neurodyn Aussie V2.0 |
Ibramed Equipamentos Medicos |
Fabio Alexandre Pinto |
| K202716 |
05/20/2021 |
Ignite Anatomic Shoulder System |
Ignite Orthopedics LLC |
Matt Purdy |
| K202832 |
05/26/2021 |
Implacil Implant System |
Implacil de Bortoli Material Odontologico Ltda |
Thiago Toni |
| K203698 |
05/04/2021 |
CoLink Sfx Implant System |
In2Bones USA, LLC |
Christine Scifert |
| K210689 |
05/12/2021 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
Larry Boucher |
| K203282 |
05/19/2021 |
TECHFIT Patient-Specific Maxillofacial System |
Industrias Medicas Sampedro S.A.S. |
Leidy Johanna Toro Gonzalez |
| K203655 |
05/04/2021 |
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) |
Innovative Health, LLC. |
Rick Ferreira |
| K210816 |
05/18/2021 |
True Tulip, True M.I.S. |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K210942 |
05/14/2021 |
MicroFrance Monopolar and Bipolar Electrosurgical Instruments |
Integra MicroFrance |
Malena Zammetti |
| K200893 |
05/04/2021 |
ProntoPump Sterile Tube Set |
IPAX, Inc |
Jeff Baldwin |
| K202527 |
05/21/2021 |
Zio ECG Utilization Software (ZEUS) System |
iRhythm Technologies, Inc. |
Gabrielle Logan |
| K202359 |
05/21/2021 |
Zio Monitor |
iRhythm Technologies, Inc. |
Rich Laguna |
| K210536 |
05/28/2021 |
Irrisept Antimicrobial Wound Lavage |
Irrimax Corporation |
Christy Coleman |
| K203525 |
05/05/2021 |
D function |
ITO CO., LTD. |
Takeshi Kobayashi |
| K202138 |
05/14/2021 |
Cardiac Trigger Monitor |
Ivy Biomedical Systems, Inc. |
Alejandra Aceves |
| K203377 |
05/20/2021 |
VR101 Lubricating Intravaginal Ring |
J3 Bioscience, Inc. |
R. Tyler McCabe |
| K210217 |
05/17/2021 |
Needleless Connector |
Jiangsu Caina Medical Co.,Ltd |
Jianwei Pan |
| K203583 |
05/20/2021 |
YUWELL infrared ear thermometer: YHT101, YHT200 |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd |
Yuzhuo Wang |
| K210304 |
05/04/2021 |
Surgical Mask |
Jin Pin Electrical CO., LTD. Zhuhai S.E.Z. |
Rongfeng Yu |
| K203572 |
05/07/2021 |
Karl Storz Radel Sterilization Trays |
Karl Storz Endoscopy America Inc |
Leigh Spotten |
| K202272 |
05/11/2021 |
HD Mediastinoscope |
Karl Storz Endoscopy America, Inc. |
Winkie Wong |
| K202899 |
05/20/2021 |
Procedure Mask, Surgical Mask |
Kenpax International Limited |
Solomon Chen |
| K202430 |
05/02/2021 |
Kerecis Reconstruct |
Kerecis Limited |
Gudmundur Fertram Sigurjonsson |
| K202747 |
05/14/2021 |
Klarity Bolus |
Klarity Medical & Equipment (GZ) Co., Ltd. |
Lucy Li |
| K210066 |
05/06/2021 |
ImagePilot |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K202521 |
05/04/2021 |
PtoleMedic System |
Lento Medical Innovation, Inc. |
David W. Schlerf |
| K200704 |
05/27/2021 |
ZedView |
Lexi Co., Ltd. |
Takao Kusunoki |
| K202973 |
05/11/2021 |
HANAROSTENT Benefit Biliary (NNN) |
M.I.Tech Co., Ltd. |
Inae Kim |
| K211253 |
05/26/2021 |
PlasmaWave |
ManaMed, Inc. |
Trevor Theriot |
| K203409 |
05/03/2021 |
MC3 Crescent Jugular Dual Lumen Catheter |
MC3, Inc. |
Martha Rumford |
| K202919 |
05/20/2021 |
ATS 5000 Automatic Tourniquet Instrument |
McEwen and Associates Consulting Ltd. |
Julie Kerr |
| K211004 |
05/13/2021 |
GMK Spherika Femurs and Fixed Tibial Trays Plus |
Medacta International SA |
Stefano Baj |
| K210153 |
05/12/2021 |
NextAR RSA Platform |
Medacta International SA |
Stefano Baj |
| K202578 |
05/06/2021 |
KardiFlex NC Coronary Dilatation Catheter |
Medcaptain Life Science Co., Ltd. |
David Xia |
| K200573 |
05/14/2021 |
BoneTrust Mini Implant System |
Medical Instinct Deutschland GmbH |
Jan Worlitz |
| K210755 |
05/07/2021 |
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) |
Meditech Gloves SDN BHD |
Effendi Tenang |
| K203135 |
05/04/2021 |
Medline Vacu-line Suction Aspirator |
Medline Industries, Inc. |
Kelsey Closen |
| K211344 |
05/28/2021 |
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems |
Medos International SARL |
Ariell Joiner |
| K210728 |
05/06/2021 |
CONDUIT Instruments |
Medos International, SARL |
Christine Cahillane |
| K211001 |
05/20/2021 |
C-Qual MÖ Breastboard; MonarchÖ Overhead Arm Positioner |
MEDTEC, Inc. dba CIVCO Medical Solutions and CIVCO |
Alena Newgren |
| K211258 |
05/26/2021 |
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, |
Medtronic Sofamor Danek USA, Inc. |
Kelly McDonnell |
| K210425 |
05/24/2021 |
Catalyft PL Expandable Interbody System |
Medtronic Sofamor Danek, USA Inc. |
Alex Underberg |
| K211057 |
05/27/2021 |
LigaPASS« Spinal System, CD HorizonÖ Spinal System |
Medtronic, Inc. |
Taylor Gold West |
| K211304 |
05/28/2021 |
LINQ II Insertable Cardiac Monitor |
Medtronic, Inc. |
Andrea Artman |
| K203724 |
05/25/2021 |
HeRO Graft, HeRO Adapter |
Merit Medical Systems, Inc. |
Susan Christensen |
| K211098 |
05/26/2021 |
Breast Volume Navigator (BVN) Model G-2000 |
MetriTrack, Inc. |
Mirela Wohlford |
| K201192 |
05/21/2021 |
Impla-NX (Model: ISE-270M) |
MICRO-NX Co., Ltd. |
Jong-Kun Lee |
| K211423 |
05/21/2021 |
Rover |
Micro-X Limited |
Derek Rogers |
| K200768 |
05/04/2021 |
Rebellion, Phantom Multi-Bite Kerrison Rongeurá |
Morpheus AG |
Timo Rack |
| K202667 |
05/18/2021 |
Personal Lubricant Jelly |
Nantong Health & Beyond Hygienic Products Inc. |
Michael Zhu |
| K210496 |
05/26/2021 |
Nautilus Nitrile Exam Gloves |
Nautilus Gloves LLC |
Mesh Gelman |
| K210915 |
05/25/2021 |
Pathfinder Endoscope Cap |
Neptune Medical, Inc. |
Alex Tilson |
| K211301 |
05/28/2021 |
Pathfinder Endoscope Overtube |
Neptune Medical, Inc. |
Alex Tilson |
| K210358 |
05/21/2021 |
Neurescue device |
Neurescue Aps |
Habib Forest |
| K190703 |
05/22/2021 |
Neuro-IOM system with Neuro-IOM.NET software |
Neurosoft Ltd |
Eugene Polezhaev |
| K201949 |
05/02/2021 |
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K201461 |
05/21/2021 |
Manual Wheelchair, Model A011 |
Ningbo Shenyu Medical Equipment Co., Ltd. |
Zhou Yuefeng |
| K202709 |
05/18/2021 |
Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges |
Ningbo Verykind Medical Device Co., Ltd. |
Hong Pengfei |
| K211134 |
05/27/2021 |
BIB Stent Placement Catheter |
NuMED, Inc |
Nichelle LaFlesh |
| K210439 |
05/12/2021 |
NuVasive MOD-EX XLIF Interbody System |
NuVasive, Incorporated |
Manthan J. Damani |
| K210214 |
05/24/2021 |
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System |
NuVasive, Incorporated |
Olga Lewis |
| K210025 |
05/28/2021 |
INVU by Nuvo |
Nuvo-Group Ltd. |
Chen Rubinstein |
| K210540 |
05/19/2021 |
Ohlendorf Clear Aligner |
Ohlendorf Appliance Laboratory |
Kevin Ohlendorf |
| K203682 |
05/17/2021 |
Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action |
Olympus Winter & Ibe GmbH |
Katharina Campbell |
| K210366 |
05/07/2021 |
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
Freddy Low |
| K202971 |
05/06/2021 |
DRPx Locking Distal Radius Plate System |
Orthopaedic Implant Company |
Douglas Fulton |
| K211112 |
05/05/2021 |
OIC External Fixation System |
Orthopaedic Implant Company |
Douglas Fulton |
| K202458 |
05/18/2021 |
BonOs Inject, Pedicle screw kits, Cement pusher |
Osartis GmbH |
Volker Stirnal |
| K210051 |
05/26/2021 |
OTE MPS 045 Multi-purpose Lens Care Solution |
OTE North America LLC |
Nathan Rosenberg |
| K210187 |
05/19/2021 |
Overjet Dental Assist |
Overjet, Inc. |
Adam Heroux |
| K210369 |
05/13/2021 |
Powder Free Nitrile Examination Glove |
Pastel Glove Sdn Bhd |
Siou Wei Law |
| K211292 |
05/26/2021 |
Fassier-Duval Telescopic IM System |
Pega Medical Inc. |
Enrique Garcia |
| K210485 |
05/13/2021 |
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) |
PENTAX of America, Inc. |
William Goeller |
| K203440 |
05/20/2021 |
Penumbra System (Reperfusion Catheter RED 62) |
Penumbra, Inc. |
Aditi Kolla |
| K210880 |
05/19/2021 |
Vereos PET/CT |
Philips Medical Systems Nederland B.V. |
Nimit Shah |
| K211275 |
05/25/2021 |
AirMax Procedure Mask |
PremiumEStore, LLC |
Brent Dillie |
| K200555 |
05/13/2021 |
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) |
Prevest Denpro Limited |
Atul Modi |
| K210298 |
05/05/2021 |
GR-14 Resin System |
Pro3dure Medical GmbH |
Frank Gischer |
| K211115 |
05/13/2021 |
A1AT Genotyping Test |
Progenika Biopharma S.A., a Grifols company |
Diego Tejedor |
| K210553 |
05/19/2021 |
Steam-Dot Process Indicator |
Propper Manufacturing Co., Inc. |
Andrew Sharavara |
| K201576 |
05/19/2021 |
Disposable Latex Powder Free Examination Gloves (Non-sterile) |
PT. Universal Gloves |
Sutopo Sutopo |
| K210218 |
05/07/2021 |
SURGICAL MASK, Model Name:C015 |
Qingdao Hainuo Biological Engineering Co., Ltd. |
Raphael Wang |
| K211105 |
05/17/2021 |
Ear-Friendly Mask |
Ray Co., Ltd. |
Changhwan Lee |
| K210072 |
05/14/2021 |
HOLOSCOPE-i |
Real View Imaging Ltd. |
Yehudit Kraizer |
| K203481 |
05/13/2021 |
CryoVIVE |
Recens Medical Inc. |
Yeonui Lee |
| K210188 |
05/28/2021 |
coraCross |
Reflow Medical |
Krystal Santiago |
| K210979 |
05/13/2021 |
Prelivia |
Rehabtronics Inc. |
Mike Pearson |
| K210874 |
05/13/2021 |
Reliance Spinal Screw System |
Reliance Medical Systems, LLC |
Bret M Berry |
| K202031 |
05/06/2021 |
Talent-Pro Electromagnetic Stimulator |
Remed Co., Ltd |
Yoonsoo Nam |
| K203847 |
05/07/2021 |
Reprocessed Tri Pulse Compression Garment |
RENU Medical, Inc |
Darren DeMerritt |
| K203226 |
05/14/2021 |
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM |
Richard Wolf Medical Instruments Corporation |
Michael Loiterman |
| K210535 |
05/24/2021 |
UltraLight LED System |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K210426 |
05/13/2021 |
HS40 Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
Ju Jee Young |
| K210200 |
05/14/2021 |
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock |
Set Medikal Sanayi Ve Ticaret Anonim Sirketi |
Mehice Ozturk |
| K210774 |
05/14/2021 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Shandong Jieshi Medical Products Co.,Ltd |
Li Biao |
| K210780 |
05/14/2021 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Shandong Shangwei Medical Products Co.,Ltd |
Li Hua |
| K210520 |
05/26/2021 |
Disposable Synthetic Examination Gloves |
Shandong Shengshixincheng Medical Science & Technology Co., |
Ping Wang |
| K201929 |
05/14/2021 |
KDL Angiography Catheter |
Shanghai Kindly Medical Instruments Co., Ltd. |
Xu Jianhai |
| K203196 |
05/26/2021 |
Peak flow meter |
Shanghai Sonmol Medical Equipment Co., Ltd. |
Li Yong Xu |
| K210119 |
05/21/2021 |
IPL Hair Removal Device (Model: KCA423) |
Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd |
Cheryl Yang |
| K202866 |
05/19/2021 |
TENS & EMS Device |
SHenzhen Jianfeng Electronic Technology Co., Ltd. |
Feng Wen |
| K210435 |
05/12/2021 |
Automatic Arm Electronic Blood Pressure Monitor |
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. |
Aaron Lin |
| K210557 |
05/12/2021 |
Symbia VA10A Family |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| DEN190043 |
05/27/2021 |
SafeBreak Vascular |
Site Saver, Inc. d/b/a Lineus Medical |
Lemuel V. Clement |
| K203566 |
05/13/2021 |
Tablet Application |
Smith & Nephew |
Sean Reynolds |
| K211246 |
05/24/2021 |
LEGION CR Porous Plus HA Femoral Components |
Smith & Nephew, Inc. |
Leah Hawkins |
| K202299 |
05/21/2021 |
Ultrasonic Surgical Aspirator System |
SMTP Technology Co., Ltd |
Songtao Zhan |
| K210682 |
05/04/2021 |
SOTA Cloud Imaging |
Sota Precision Optics, Inc. dba SOTA Imaging |
Edward Johansen |
| K210669 |
05/04/2021 |
Quantum Mini Ventilation Module |
Spectrum Medical Ltd. |
Colleen Powell |
| K210737 |
05/12/2021 |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate |
STERIS Corporation |
Jennifer Nalepka |
| K203710 |
05/03/2021 |
Storz Medical MAGNETOLITH Muscle Stimulator |
Storz Medical AG |
Pavel Novak |
| K211313 |
05/25/2021 |
MAXFRAME Multi-Axial Correction System (aka MAXFRAME) |
Synthes (USA) Products, LLC |
Suchitra Basu |
| K211307 |
05/27/2021 |
GalaSTITCH Absorbable Monofilament Suture |
Tepha, Inc. |
Jodie Giordano |
| K210529 |
05/06/2021 |
Dr. Yglo Wart Remover |
The OTC Lab Healthcare B.V. |
Albert Swane |
| K210451 |
05/05/2021 |
OrthoGold 100 |
Tissue Regeneration Technologies, LLC |
John Warlick |
| K203760 |
05/25/2021 |
Tokuyama Universal Bond II |
Tokuyama Dental Corporation |
Keith A. Barritt |
| K202593 |
05/19/2021 |
Turbett Instrument Pod |
Turbett Surgical Inc. |
Rob Turbett |
| K202697 |
05/13/2021 |
United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask |
United Sewing Automation Inc. |
Benjamin Webb |
| K202921 |
05/04/2021 |
Uro-G Cystoscope |
UroViu Corporation |
Thomas Lawson |
| K202860 |
05/11/2021 |
Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A |
Valley Contax, Inc. |
Josh Adams |
| K202862 |
05/14/2021 |
Gx-IVF, Gx-TL, Gx-MOPS PLUS |
Vitrolife Sweden AB |
Sarah Hood Hagberg |
| K210086 |
05/20/2021 |
Vitals360 Multi-Vitals Mobile Monitor |
VoCare, Inc. |
Steve Peabody |
| K200607 |
05/28/2021 |
LINK MobileLink« Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters |
Waldemar Link GmbH & Co. KG |
Stafanie Fuchs |
| K202924 |
05/13/2021 |
LinkSymphoKnee System |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K210675 |
05/03/2021 |
EasyWhip |
Winter Innovations, Inc. |
Lia Winter |
| K203228 |
05/11/2021 |
DART-FIRE EDGE Cannulated Screw System |
Wright Medical |
Michael Mullins |
| K203832 |
05/07/2021 |
FuseForceÖ Flex Dynamic Compression System |
Wright Medical |
Jonathan DiMotta |
| K210967 |
05/11/2021 |
Air Pressure Therapy System: VU-IPC06 |
Xiamen Weiyou Intelligent Technology Co., Ltd. |
Yong Sun |
| K210257 |
05/20/2021 |
Xoran Workstation, Model 10050 |
Xoran Technologies LLC |
Mark McGarrow |
| K203806 |
05/21/2021 |
JWX-1 Plus (Navigo 16/Navigo 24) |
Yamaha Motor CO., LTD. |
Michiyo Yamazaki |
| K203415 |
05/20/2021 |
Surgical Isolation Gown |
Yanbian Pacific Textile Co., LTD |
Juan Zhuang |
| K210799 |
05/14/2021 |
Powder Free Vinyl Patient Examination Gloves |
Yunnan Huazhiyuan Medical Technology Co., Ltd. |
Yun Gao |
| K210460 |
05/17/2021 |
NitriTec Vinyl Glove Powder Free Blue |
Zhonghong Pulin Medical Products Co.,Ltd. |
Jia Yongmin |
| K203218 |
05/04/2021 |
CaP Spheres Pellet Pack |
Zimmer Biomet Spine Inc. |
Leo Su |
| K210829 |
05/18/2021 |
Persona Revision Knee System Femoral Metaphyseal Cones |
Zimmer, Inc. |
Romil Sheth |
