| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K210347 |
04/26/2021 |
VSP System |
3D Systems |
Scott Brewer |
| K210605 |
04/29/2021 |
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation |
3M Company |
Hilary Hovde |
| K211190 |
04/23/2021 |
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) |
3M Company, Unitek Orthodontic Products |
Yanine Garcia-Quezada |
| K203550 |
04/08/2021 |
ActivSight Intraoperative Imaging System |
Activ Surgical, Inc. |
Matthew King |
| K203571 |
04/09/2021 |
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A. Bonafini |
| K210685 |
04/06/2021 |
AcQCross Qx Integrated Transseptal Dilator/Needle |
Acutus Medical Inc. |
Sarah Clay |
| K210850 |
04/05/2021 |
ADAS 3D |
Adas3D Medical S.L |
Antonio Riu |
| K191479 |
04/11/2021 |
Velocity Alpha Highspeed Surgical Drill System |
adeor Medical AG |
Viktor Rundel |
| K202830 |
04/15/2021 |
Axiostat Patch |
Advamedica Inc. |
Leo Mavely |
| K202992 |
04/14/2021 |
BriefCase, RIB Fractures Triage (RibFx) |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K210436 |
04/12/2021 |
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere |
Alcon Laboratories Inc. |
Alicia Plesnarski |
| K203742 |
04/09/2021 |
IdentiTi ALIF Standalone Interbody System |
Alphatec Spine Inc. |
Cynthia Dorne |
| K203570 |
04/22/2021 |
Mya Joy PLUS Breast Pump |
Ameda, Inc. |
Carolin Archibald |
| K210701 |
04/07/2021 |
CATALYS Precision Laser System |
AMO Manufacturing USA, LLC |
Laarni Ricafort |
| K201138 |
04/14/2021 |
AMSure« Single Use Saline Topical Solution |
Amsino Medical Inc. |
Torsten Nilson |
| K203801 |
04/06/2021 |
Disposable Surgical Face Mask |
Anhui Jiabao Protective Equipments Co., Ltd |
Mark Zhang |
| K202987 |
04/29/2021 |
Rescue Pulmonary Grasping Forceps |
Anrei Medical (Hangzhou) Co., Ltd |
Huibing Yang |
| K210660 |
04/27/2021 |
Stone Retrieval Balloon Catheter |
Anrei Medical (Hangzhou) Co., Ltd. |
Huibing Yang |
| K203605 |
04/23/2021 |
SteriTrak |
Arbutus Medical Inc. |
Michael Cancilla |
| K201257 |
04/06/2021 |
MI.BO. « MyoBoost EMS System (MB-1000, MB-600, MB-400) |
Arrive Systems Inc |
Aseem Gupta |
| K203495 |
04/19/2021 |
Arthrex SwiveLock Anchor |
Arthrex Inc. |
Kelsey Roberts |
| K210087 |
04/12/2021 |
Athena Surgical RMUS System |
Athena Surgical, LLC |
Greg Slusser |
| K201457 |
04/06/2021 |
Auxein Brand Vertaux 5.5 mm Pedicle Screw System |
Auxein Medical Private Limited/71164 |
Gaurav Luthra |
| K202884 |
04/13/2021 |
SR-1 Skin Treatment System |
AVAVA, Inc. |
Lewis Levine |
| K191951 |
04/27/2021 |
Avazzia OTC TENS for aesthetics, model BEST-AV1Ö: EZZI-LIFTÖ Device |
Avazzia, Inc |
Tammy Lahutsky |
| K202768 |
04/01/2021 |
KOSMO Femoral Stem |
b-One Ortho Corp. |
Allison Gecik |
| K210483 |
04/21/2021 |
MOBIO Total Knee System |
b-ONE ORTHO, Corp. |
Allison Gecik |
| K203364 |
04/15/2021 |
MDPC-8127 |
Barco NV |
Lieven De Wandel |
| K210663 |
04/26/2021 |
Dermatological Diode Laser Systems |
Beijing HuaCheng Taike Technology Co., Ltd. |
Li Yi |
| K203276 |
04/20/2021 |
Bead Block (100 - 300╡m, 1ml), Bead Block (300 - 500╡m, 1ml), Bead Block (500 - 700╡m, 1ml), Bead Block (700 - 900╡m, 1ml), Bead Block (900 - 1200╡m, 1ml), Bead Block (100 - 300╡m, 2ml), Bead Block (300 - 500╡m, 2ml), Bead Block (500 - 700╡m, 2ml), Bead B |
Biocompatibles UK Ltd (part of Boston Scientific Corporation |
Christina Fischer |
| K210242 |
04/28/2021 |
Astroglide X Silicone Personal Lubricant |
BioFilm Inc. |
Kevin Jamil |
| K203267 |
04/30/2021 |
The BioBrace Implant |
Biorez, Inc. |
Kevin Rocco |
| K210867 |
04/21/2021 |
NuEra Tight RF, NuEra Tight RF Plus |
BIOS s.r.l. |
Eliana Russo |
| K202639 |
04/21/2021 |
si-Mochi |
Biostone Ltd |
Wei-Jen Lo |
| K203520 |
04/07/2021 |
Blustone Synergy Interbody Fusion System |
Blustone Synergy, LLC |
Tom Gentry |
| K210925 |
04/28/2021 |
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber |
Boston Scientific |
Rebecca Perrine |
| K203132 |
04/15/2021 |
AXIOS Stent and Electrocautery Enhanced Delivery System |
Boston Scientific Corporation |
Aparna Philip |
| K200260 |
04/26/2021 |
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System |
Boston Scientific Corporation |
Heidi Shearer |
| K211072 |
04/27/2021 |
Safety Trocar Cannula |
Boston Scientific Corporation |
Lingling Guo |
| K203681 |
04/09/2021 |
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review |
Brainlab AG |
Chiara Cunico |
| K203616 |
04/16/2021 |
Brainsway Deep (DTMS) System |
Brainsway Ltd. |
Ahava Stein |
| K203735 |
04/23/2021 |
Brainsway Deep TMS System |
Brainsway Ltd. |
Ahava Stein |
| K203390 |
04/14/2021 |
Artimes pro Balloon Dilatation Catheter |
BrosMed Medical Co., Ltd. |
Wade Zhang |
| K203767 |
04/02/2021 |
Pristine Long-Term Hemodialysis Catheter |
C B Bard, Inc |
Arieona Boyle |
| K210900 |
04/12/2021 |
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 |
Canon Medical Systems Corporation |
Paul Biggins |
| K203314 |
04/23/2021 |
Cartesion Prime (PCD-1000A/3) V10.8 |
Canon Medical Systems Corporation |
Paul Biggins |
| K210340 |
04/01/2021 |
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Paul Biggins |
| K210716 |
04/06/2021 |
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K202441 |
04/02/2021 |
Eclipse II with Smart Noise Cancellation |
Carestream Health, Inc. |
Duane Gutowski |
| K210145 |
04/21/2021 |
Nitrile Glove Powder Free Blue |
Changzhou Universal Medical Equipment CO. LTD. |
Xiaohai Wan |
| K202457 |
04/29/2021 |
M1 Surgical Face Mask |
CHISON Medical Technologies Co., Ltd. |
Qifei Liu |
| K202759 |
04/21/2021 |
Disposable medical surgical mask |
Chongqing COE Display Technology Co., Ltd. |
Liu Qingjun |
| K201903 |
04/09/2021 |
Electric breast pump (Models: RH-228 and RH-338) |
Cixi Ruihong Electric Appliance Co., Ltd. |
Zhangkelong Zhangkelong |
| K200919 |
04/12/2021 |
Idys ALIF 3DTi |
CLARIANCE |
Fadwa Bahr |
| K202032 |
04/01/2021 |
Idys LLIF 3DTi |
Clariance, SAS |
Fadwa Bahr |
| K210251 |
04/02/2021 |
ClearPath Disposable Introducer |
ClearMind Biomedical |
Sheng-Chi (aka Vance Lin) Lin |
| K202183 |
04/02/2021 |
Porcine Mineral Collagen Composite |
Collagen Matrix, Inc. |
Gloria Zuclich |
| K203421 |
04/19/2021 |
Triathlon AS-1 |
Conformis Inc. |
Mary Kruitwagen |
| K202757 |
04/28/2021 |
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor |
Contec Medical Systems Co., Ltd. |
Xueyong Li |
| DEN200038 |
04/01/2021 |
Gili Pro BioSensor (also known as ôGili BioSensor Systemö) |
ContinUse Biometrics Ltd. |
Sagi Polani |
| K210734 |
04/06/2021 |
Endovascular Dilator and Sets |
Cook Incorporated |
Michael Venezia |
| K210626 |
04/23/2021 |
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter |
Cordis Corporation |
Wai Morgan |
| K210539 |
04/15/2021 |
CoreLink Midline Fixation System |
CoreLink, LLC |
Steven Mounts |
| K203751 |
04/12/2021 |
OMNIVision system |
Corin USA |
Lucinda Gerber |
| DEN200055 |
04/09/2021 |
GI Genius |
Cosmo Artificial Intelligence - AI, LTD |
Steven A. Kradjian |
| K210338 |
04/15/2021 |
Edge Insulated Blade Electrode |
Covidien LLC |
Miranda Miles |
| K202909 |
04/02/2021 |
CreoDent Solidex Customized Abutment |
CreoDent Prosthetics, Ltd. |
Calvin Shim |
| K202243 |
04/02/2021 |
SkinPen Precision System |
Crown Aesthetics |
Marie Fogartie |
| K210197 |
04/13/2021 |
NFC-600 Automated Portable Retinal Camera |
Crystalvue Medical Corporation |
Oliver Lin |
| K203012 |
04/11/2021 |
Surgical Mask |
Customfab, INC. |
Erentia Gillmer |
| K203353 |
04/22/2021 |
DVT-PRO |
Daesung Maref Co., LTD |
Su Hyeon So |
| K203517 |
04/16/2021 |
Saige-Q |
DeepHealth, Inc. |
A. Gregory Sorensen |
| K202084 |
04/09/2021 |
DeepLook PRECISE |
DeepLook Inc. |
Steven Schwadron |
| K202928 |
04/02/2021 |
DV. Target |
Deepvoxel INC |
Jerry Liu |
| K203816 |
04/02/2021 |
DeGen Navigated Instrumentation |
DeGen Medical |
Craig Black |
| K210134 |
04/19/2021 |
Dentis s-Clean s-Line |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K200271 |
04/16/2021 |
rainbow CT |
Dentium Co., Ltd (ICT Branch) |
Sangwoo Lee |
| K200270 |
04/16/2021 |
rainbow MCT |
Dentium Co., Ltd (ICT Branch) |
Sangwoo Lee |
| K203532 |
04/28/2021 |
BI-MENTUMÖ ALTRX« Dual Mobility Liner |
Depuy Ireland UC |
Erin Combs |
| K203230 |
04/02/2021 |
Global Shoulder and Delta CTA systems |
DePuy lnc. |
Megan Bernier |
| K210752 |
04/14/2021 |
HydroMARK Breast Biopsy Site Marker |
Devicor Medical Products, Inc. |
Diane Sung |
| K210018 |
04/11/2021 |
Disposable Medical Mask |
Diasia Biomedical Technology Co., Ltd. |
Jason Luo |
| K210169 |
04/16/2021 |
Hair Growth Device |
Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd |
Liu Jianwen |
| K192190 |
04/23/2021 |
Solax Electric Scooter |
Dongguan Prestige Sporting Goods Co., Ltd |
Zhang Zhao |
| K200978 |
04/16/2021 |
Electric Wheelchair (Model: S7110) |
Dongguan Prestige Sporting Goods Co., Ltd. |
Zhang Zhao |
| K202632 |
04/08/2021 |
Electric wheelchair (S7204/S7205) |
Dongguan Prestige Sporting Goods Co., Ltd. |
Zhang Zhao |
| K202655 |
04/05/2021 |
Disposable Medical Mask |
Dongguan Runlin Medical Supplies Technology Co., LTD |
Weiming Chen |
| K202258 |
04/26/2021 |
ERISE Laser handpiece |
EL.EN. Electronic Engineering Spa |
Paolo Peruzzi |
| K210681 |
04/06/2021 |
SiteSeal SV |
Ensite Vascular |
Thomas Reidy |
| K202206 |
04/01/2021 |
AMG PMP Pediatric |
Eurosets S.r.l. |
Katia Vescovini |
| K203533 |
04/21/2021 |
VASSALLO GT |
Filmecc Co., Ltd |
Toshiya Osawa |
| K203449 |
04/14/2021 |
F&P Visairo NIV Mask Range |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K210182 |
04/07/2021 |
PANAMAÖ Anterior Cervical Plate (ACP) System |
FloSpine |
Peter Harris |
| K210276 |
04/16/2021 |
Disposable Nitrile Gloves |
Fujian Ercon Medical Management Co., Ltd. |
Lin Ruijin |
| K210162 |
04/09/2021 |
Endoscope Model EI-740D/S |
FUJIFILM Corporation |
Randy Vader |
| K210890 |
04/23/2021 |
GPS Cervical Spacers |
G Surgical LLC |
Donald Grafton |
| K203786 |
04/30/2021 |
MAC 7 - Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
Lee Bush |
| K210982 |
04/28/2021 |
AMX Navigate |
GE Medical Systems, LLC |
Martha Kamrow |
| K210556 |
04/21/2021 |
Preview Shoulder |
Genesis Software Innovations |
Matt Miller |
| K202387 |
04/23/2021 |
Disposable Surgical Face Mask |
Guangdong Bida Medical Technology Co., Ltd. |
Zhang Rong |
| K202761 |
04/11/2021 |
Medical Surgical Mask (Non-sterile) |
Guangdong GoodFeeling Hygiene Material Tec Co., Ltd. |
Zheng Zhijin |
| K210023 |
04/02/2021 |
Surgical Face Mask |
Guangdong Winsun Personal Care Products Co.,Ltd |
Dong Pingping |
| K203646 |
04/22/2021 |
Disposable Medical Face Mask |
Guangzhou Mei Yi Kang Medical Technology CO., LTD. |
Lou Yonghui |
| K210944 |
04/29/2021 |
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) |
Harbour Health LLC |
Jared Koenig |
| K202055 |
04/16/2021 |
Looper (Model: ZX-579S) |
Heat In A Click LLC |
Guy Levi |
| K203480 |
04/05/2021 |
DOUBLEFLO system |
Hemodia SAS |
Adeline Theron |
| K210893 |
04/22/2021 |
Restoration Anatomic Shell |
Howmedica Osteonics Corp. a.k.a. Stryker Orthopaedics |
Alexandra Kirby |
| K203824 |
04/19/2021 |
VPS Impression Material |
Hygedent INC. |
Peng Wang |
| K202043 |
04/23/2021 |
Secret Duo |
Ilooda Co Ltd |
Kevin Walls |
| K203489 |
04/20/2021 |
SEFRIA PCP Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
Wenying (Jessica) Zhu |
| K202136 |
04/13/2021 |
IDS Cortisol |
Immunodiagnostic Systems Ltd. |
Mick Henderson |
| K203473 |
04/19/2021 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K210996 |
04/23/2021 |
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing |
Imperative Care Inc. |
Kristin Ellis |
| K200329 |
04/22/2021 |
IDCAM Dental Implants |
Implants Diffusion International |
Rony Boukhris |
| K211013 |
04/30/2021 |
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 |
Inari Medical, Inc. |
Larry Boucher |
| K210988 |
04/21/2021 |
Yushan X-Ray Flat Panel Detector with DROC |
InnoCare Optoelectronics Corp. |
Yumei Cheng |
| K210808 |
04/15/2021 |
Instylla Microcatheter 1.2 |
Instylla, Inc. |
Jennifer Greer |
| K210993 |
04/30/2021 |
CereLink ICP Monitor |
Integra LifeSciences Production Corporation |
MaryBeth Carson |
| K203240 |
04/27/2021 |
AccelX Abutments |
Integrated Dental Systems LLC |
David Singh |
| K210629 |
04/12/2021 |
SecurAcath |
Interrad Medical Inc |
Denise Lenz |
| K210918 |
04/26/2021 |
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K203210 |
04/12/2021 |
Invacare Platinum 5NXG Oxygen Concentrator |
Invacare Corporation |
Elijah Wreh |
| K210312 |
04/23/2021 |
PlutoX Digital Intraoral X-Ray Imaging System |
iRay Technology Taicang Ltd. |
Wei Pan |
| K203701 |
04/15/2021 |
Locator Overdenture Implant System |
Ivory Super Holdco Inc. / Zest Anchors LLC |
Marysa Loustalot |
| K210290 |
04/30/2021 |
JACE Medical Thoracic Plating System |
JACE Medical, LLC |
Scott Steffensmeier |
| K200463 |
04/07/2021 |
Huber Needle Infusion Set, Safety Huber Needle Infusion Set |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K201718 |
04/15/2021 |
GD Disposable Medical Face Mask |
Jiangsu Guangda Medical Material Group Co., Ltd. |
George Zhang |
| K203310 |
04/02/2021 |
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System |
Jiangsu Synecoun Medical Technology Co., Ltd. |
Yue Li |
| K203805 |
04/20/2021 |
Disposable Nitrile Examination Gloves |
Jiangsu Yanfang Medical Technology Co., Ltd. |
Wei Kaijian |
| K210007 |
04/23/2021 |
Face Mask |
Jinhua Jingdi Medical Supplies Co., Ltd |
Hu Xiaojiang |
| K210345 |
04/23/2021 |
2MP Monochrome LCD Monitor MS-S200 |
Jvckenwood Corporation |
Hideki Tengeiji |
| K202506 |
04/19/2021 |
Karma Powered Wheelchair |
Karma Medical Products Co., Ltd. |
Ke-Min Jen |
| K210885 |
04/23/2021 |
Dayspring |
Koya Medical, Inc. |
Andy Doraiswamy |
| K203472 |
04/02/2021 |
KMTI Hip Replacement System |
Kyocera Medical Technologies, Inc. |
Anthony DeBenedictis |
| K202129 |
04/01/2021 |
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Pre |
Largan Medical Co., Ltd. |
Amy Tien |
| K203491 |
04/07/2021 |
PicoLO Nd: YAG Picosecond Laser System |
Laseroptek Co., Ltd. |
Hong Chu |
| K211010 |
04/26/2021 |
Illusion Aligners |
Laxmi Dental Exports Pvt Ltd |
Sameer Merchant |
| K201171 |
04/02/2021 |
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable |
LEONI Fiber Optics, Inc. |
Martin Trapp |
| K210549 |
04/22/2021 |
ARx Spinal System |
Life Spine, Inc. |
Angela Batker |
| K210061 |
04/30/2021 |
ProLift Lateral HELO Fixated |
Life Spine, Inc. |
Angela Batker |
| K202915 |
04/23/2021 |
IRIS Thermocoagulator and Digital Colposcope |
Liger Medical, LLC |
Wm. Dean Wallace |
| K210554 |
04/06/2021 |
Physica system |
Limacorporate S.p.A. |
Giuseppe Valenti |
| K202154 |
04/01/2021 |
B-Capta |
LivaNova Deutschland GmbH |
Mattia Ronchetti |
| K210130 |
04/05/2021 |
Stockert S5 System |
LivaNova Deutschland GmbH |
Florian Goetz |
| K203580 |
04/30/2021 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K210851 |
04/21/2021 |
DiLumen Endolumenal Interventional Platform (DiLumen) |
Lumendi, LLC |
Dennis Daniels |
| K201874 |
04/20/2021 |
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 |
Maquet Critical Care AB |
David Ardanius |
| K202679 |
04/12/2021 |
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 |
McGovern Medical School |
K. Lance Gould |
| K210456 |
04/12/2021 |
Ligament Staple |
Medacta International SA |
Stefano Baj |
| K210427 |
04/20/2021 |
M.U.S.T. Midline Cortical (MC) Screw System |
Medacta International SA |
Stefano Baj |
| K210062 |
04/08/2021 |
Mectaplug PE II |
Medacta International SA |
Stefano Baj |
| K200391 |
04/28/2021 |
MPACT Extension |
Medacta International SA |
Stefano Baj |
| K203673 |
04/06/2021 |
MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) |
Medacta International SA |
Stefano Baj |
| K202748 |
04/09/2021 |
Enteral Feeding Catheter |
Medcaptain Life Science Co., Ltd. |
David Xia |
| K202619 |
04/29/2021 |
KardiFlex PTCA Balloon Dilatation Catheter |
Medcaptain Life Science Co., Ltd. |
David Xia |
| K202447 |
04/02/2021 |
Medline Orbis Surgical Gown |
Medline Industries, Inc. |
Adam Ostrower |
| K210482 |
04/22/2021 |
Medline UNITE REFLEX Nitinol Staple System |
Medline Industries, Inc. |
Jennifer Mason |
| K203502 |
04/23/2021 |
MEDO-Thyroid |
MEDO DX Pte. Ltd. |
Dornoosh Zonoobi |
| K203264 |
04/26/2021 |
MicroDose Injector |
MedOne Surgical, Inc. |
Bruce Beckstein |
| K210637 |
04/30/2021 |
CD HorizonÖ Spinal System |
Medtronic |
Shweta Sharma |
| K210420 |
04/19/2021 |
Goblin and Goblin LS Pedicle Screw Systems |
Medynus Inc. |
David Shin |
| K202617 |
04/14/2021 |
Metapex Plus |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K202729 |
04/08/2021 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K210600 |
04/16/2021 |
MOLLI |
MOLLI Surgical, Inc. |
Fazila Seker |
| K210981 |
04/29/2021 |
Pure Vu System |
Motus GI Medical Technologies Ltd. |
Mark Pomeranz |
| K210525 |
04/22/2021 |
MY01 Continuous Compartmental Pressure Monitor |
MY01 Inc. |
Charles Allan |
| K203000 |
04/09/2021 |
KeyPrint KeySplint Hard |
Mycone Dental Supply Co. Inc. (DBA Keystone Industries) |
Diamond Bynum |
| K203782 |
04/01/2021 |
Nanox Cart X-ray System |
Nano-x Imaging Ltd. |
Yuval Shapiro |
| K201853 |
04/23/2021 |
Naton Disposable Surgical Face Mask |
Naton Biotechnology (Beijing) Co., Ltd. |
Shanshan Zou |
| K203500 |
04/13/2021 |
RetCam Envision |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
Sanjay Mehta |
| DEN200046 |
04/23/2021 |
Neurolutions Upper Extremity Rehabilitation System |
Neurolutions, Inc. |
Kern J. Bhugra |
| K203835 |
04/23/2021 |
MIS Solution |
Next Science, LLC |
Courtney Narain |
| K202647 |
04/26/2021 |
Surgical Mask |
Ningbo Green Textile Co., Ltd. |
Carol No Last Name Provided |
| K210621 |
04/28/2021 |
Oral/Enteral Syringe |
Ningbo Tianyi Medical Appliance Co., Ltd. |
Wenyu Zhang |
| K203277 |
04/28/2021 |
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K201611 |
04/02/2021 |
Apex Knee System |
OMNIlife science |
Dipti Dharia |
| K202228 |
04/01/2021 |
Omron Model BP7900 Blood Pressure Monitor + EKG |
Omron Healthcare, Inc. |
Renee Thornborough |
| K210658 |
04/13/2021 |
Volition Plating System |
Ortho Solutions UK Ltd |
Andy Leither |
| K210157 |
04/20/2021 |
SOLE Medial Column Fusion Plate |
Orthofix SRL |
Gianluca Ricadona |
| K203098 |
04/27/2021 |
STARband, STARlight, St. Louis Band |
Orthomerica Products Inc. |
David C. Kerr |
| K210121 |
04/19/2021 |
ROSA Partial Knee System |
Orthosoft d/b/a Zimmer CAS |
Kavina Veeren |
| K210754 |
04/14/2021 |
Cannulated Fasteners and Nuts |
OsteoCentric Technologies |
Todd Evans |
| K210247 |
04/30/2021 |
OsteoCentric Integrated Hip Fastener System |
OsteoCentric Technologies d.b.a. OsteoCentric Trauma |
Todd Evans |
| K203596 |
04/20/2021 |
Panthera Occlusal Appliance |
Panthera Dental Inc. |
Martine Fortin |
| K202480 |
04/22/2021 |
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 |
Parker Hannifin |
Andrew Ellinger |
| K210764 |
04/13/2021 |
Flyte |
Pelvital USA, Inc. |
Dale Wahlstrom |
| K210710 |
04/09/2021 |
PENTAX Medical Video Duedenoscope ED34-i10T2 |
PENTAX of America, Inc. |
William Goeller |
| K202365 |
04/01/2021 |
Pentax Medical Video Duodenoscope ED32-i10 |
Pentax of America, Inc. |
William Goeller |
| K203623 |
04/05/2021 |
StentBoost Mobile |
Philips India Limited |
Shruti Sancheti |
| K210692 |
04/02/2021 |
DigitalDiagnost |
Philips Medical Systems DMC GmbH |
Supriya Dalvi |
| K202750 |
04/21/2021 |
Knee+ |
Pixee Medical |
Lucie Pecheur |
| K210065 |
04/22/2021 |
Verifine Safety Type Insulin Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K203610 |
04/20/2021 |
Automatic Anatomy Recognition (AAR) |
Quantitative Radiology Solutions, LLC |
Steve Owens |
| K201563 |
04/09/2021 |
PuRE PMMA Disc |
Quest Dental USA Corp. |
Hirotaka Mori |
| K210919 |
04/30/2021 |
AcuityDRe |
Radmedix LLC |
Gabriel Issa |
| K210985 |
04/28/2021 |
1717FCC |
Rayence Co., Ltd |
Kevin Kim |
| K203121 |
04/27/2021 |
Responsive Arthroscopy Thunderbolt System |
Responsive Arthroscopy LLC |
Douglas Kohrs |
| K202325 |
04/09/2021 |
EasyPoint Blood Collection Plus |
Retractable Technologies, Inc. |
Becky Piroga |
| K210068 |
04/09/2021 |
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
Scully Kim |
| K202906 |
04/13/2021 |
EndoPilot2 |
Schlumbohm GmbH & Co. KG |
Gerald Schlumbohm |
| K210601 |
04/28/2021 |
Plato 17 Microcatheter |
Scientia Vascular LLC |
Amy McManus |
| K203436 |
04/28/2021 |
Disposable Nitrile Examination Gloves |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K203454 |
04/29/2021 |
Infrared Thermometer |
Shandong Zhushi Pharmaceutical Group Co., Ltd. |
Junhui Zhu |
| K210001 |
04/30/2021 |
HYPER AiR |
Shanghai United Imaging Healthcare Co.,Ltd. |
Xin GAO |
| K210418 |
04/09/2021 |
HYPER Focus |
Shanghai United Imaging Healthcare Co.,Ltd. |
Xin Gao |
| K193070 |
04/26/2021 |
VIVACE Electrosurgical Device |
ShenB Co Ltd. |
Sun Young Kang |
| K203170 |
04/16/2021 |
Infrared Thermometer Models: DT-8806S, DT-8807S |
Shenzhen Everbest Machinery Industry Co., LTD |
Deng Aiguo |
| K203854 |
04/23/2021 |
Pulse Oximeter |
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. |
John Liu |
| K202513 |
04/09/2021 |
Disposable Medical Face Mask-Model FM-04 |
Shenzhen Jinko Industrial Co., Ltd |
Wang Yinghui |
| K202785 |
04/08/2021 |
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
Ma chao |
| K203535 |
04/28/2021 |
Trinias |
Shimadzu Corporation Medical Systems |
Shigeru Naganishi |
| K203365 |
04/22/2021 |
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter |
Shockwave Medical, Inc. |
Danica Van |
| K210743 |
04/01/2021 |
ACUSON Redwood Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K203699 |
04/30/2021 |
syngo. CT Extended Functionalities |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K202462 |
04/23/2021 |
SIGMA Sterilization Pouch and Roll |
Sigma Medical Supplies Corporation |
Ethan Lin |
| K201047 |
04/16/2021 |
Fusion Taper System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K203601 |
04/30/2021 |
Innova Nasal Non-Vented Mask |
Sleepnet Corporation |
Jennifer Kennedy |
| K210784 |
04/02/2021 |
Extended HA Half Pins |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K203644 |
04/19/2021 |
Solevy Co. LLC Silicone Based Personal Lubricant |
Solevy Co. LLC |
Joe Mendoza |
| K203654 |
04/19/2021 |
Solevy Co. LLC Water-Based Personal Lubricant |
Solevy Co. LLC |
Joe Mendoza |
| K210964 |
04/27/2021 |
Resonic Rapid Acoustic Pulse Device |
Soliton Inc. |
Leslie Honda |
| K210839 |
04/20/2021 |
SoundBite Crossing System - Peripheral (14P) |
Soundbite Medical Solutions, Inc. |
Dominique Abecassis |
| K201024 |
04/29/2021 |
Expandable Titanium PLIF/TLIF System |
Spectrum Spine, LLC |
James Robinson |
| K210278 |
04/28/2021 |
Titan SGS |
Standard Bariatrics |
Alison Sathe |
| K203795 |
04/01/2021 |
Star RF Electrode, VIVA RF Electrode |
STARmed Co., Ltd. |
Jun-Young Jung |
| K202607 |
04/23/2021 |
Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs |
String King Lacrosse, LLC |
Thomas Frasca |
| K210088 |
04/13/2021 |
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes |
Stryker |
Jessie Duong |
| K203165 |
04/30/2021 |
Disposable Ureteral Access Sheath |
Suzhou Beyo Medical Technology Co., Ltd. |
Aline Qin |
| K203195 |
04/01/2021 |
Simpleware ScanIP Medical |
Synopsys (Northern Europe) Ltd. |
Jessica James |
| K210408 |
04/08/2021 |
DePuy Synthes Variable Angle Locking Patella Plating System |
Synthes (USA) Products, LLC |
Enrico Gindro |
| K203567 |
04/05/2021 |
Oral-B Dry Mouth Oral Rinse |
The Procter & Gamble Company |
Brenda S. Fuentes |
| K210668 |
04/01/2021 |
TSolution One Total Knee Application |
THINK Surgical, Inc. |
Meliha Mulalic |
| K210030 |
04/23/2021 |
Medical Surgical Mask |
Tianjin Aoshang Outdoor Equipment Co., Ltd. |
Xiaoning Zhang |
| K202419 |
04/16/2021 |
BIOTECH Nitrile Examination Gloves |
TK Hitech Technology Co., Ltd. |
Kanyapadsanan Suppipatthipbodee |
| K203315 |
04/15/2021 |
BLUEPRINTÖ Patient Specific Instrumentation |
Tornier SAS |
Aymen Azaiez |
| K203451 |
04/28/2021 |
TCL3 Motion Tracking System |
Tracinnovations ApS |
Stefan Glimberg |
| K210580 |
04/21/2021 |
InnovaMatrix FS |
Triad Life Sciences, Inc. |
Jon G. Hargis |
| K202403 |
04/15/2021 |
SKORE (Colors & Flavors), SKORE (Colors) |
TTK Healthcare Limited |
Daniel J. S. |
| K210961 |
04/21/2021 |
U2 Total Knee System, XPE Tibial Insert, PS PLUS |
United Orthopedic Corporation |
Lois Ho |
| K210835 |
04/20/2021 |
Identify |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K203469 |
04/19/2021 |
AI Segmentation |
Varian Medical Systems, Inc. |
Peter Coronado |
| K210647 |
04/30/2021 |
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter |
Vascular Solutions LLC |
Steph Pahl |
| K202703 |
04/06/2021 |
Vascutek Gelsoft Plus ERS Vascular Graft |
Vascutek Ltd |
Chirag Merchant |
| K203499 |
04/05/2021 |
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank |
Vatech acucera, Inc. |
Kyung Wook Kwon |
| K203512 |
04/26/2021 |
Powder Free Blue Nitrile Examination Glove |
VIP Glove SDN BHD |
Terence Lim |
| K210235 |
04/15/2021 |
Verrata PLUS Pressure Guide Wire |
Volcano Corporation |
Leilani Taylor |
| K210609 |
04/27/2021 |
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens |
VP Optics |
Daniel Yoon |
| K210300 |
04/01/2021 |
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System |
VueSonic, LLC |
Sheri Ker |
| K202134 |
04/08/2021 |
Well Lead All Silicone Foley Catheter with Temperature Sensor |
Well Lead Medical Co., LTD. |
Jenny Zhu |
| K210491 |
04/08/2021 |
CW120N |
Wide Corporation |
YeoJin Yun |
| K210493 |
04/14/2021 |
CX30N (CX30PQX) |
Wide Corporation |
YeoJin Yun |
| K202464 |
04/26/2021 |
Vital Sign Monitoring Sensor (Model :XK300) |
Xandar Kardian Inc. |
Glen (Jeong Woo) Choi |
| K201127 |
04/14/2021 |
DEFEND Ear-loop Face Masks |
Young Dental Manufacturing Co. 1, LLC |
Jose Espino |
| K193630 |
04/09/2021 |
hekaDrill |
Zethon Ltd |
Faith Green |
| K210020 |
04/28/2021 |
Medical Mask |
Zhende Medical Co., Ltd. |
Chen Ming |
| K210106 |
04/07/2021 |
Nitrile Examination Gloves |
Zhenjiang Huayang Latex Products Co., Ltd. |
Han Sheng |
| K202257 |
04/23/2021 |
Dermatological Diode Laser Systems |
Zhuolu Jontelaser Manufacturing Technology Co., Ltd. |
Karen Liu |
| K210275 |
04/02/2021 |
Polaris Spinal System |
Zimmer Biomet Spine, Inc |
Anjanet Mort |
