| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K210211 |
10/08/2021 |
PuraStat-OM |
3-D Matrix, Inc. |
Lisa Spirio |
| K211582 |
10/18/2021 |
LOQTEQ Proximal Humerus Plate 3.5 System |
aap Implantate AG |
Agnieszka Mierzejewska |
| K200865 |
10/20/2021 |
Piccolo Potassium Test System |
Abaxis, Inc. |
Dennis M Bleile |
| K212061 |
10/22/2021 |
EnSite X EP System |
Abbott |
Jamie Glaser |
| K212156 |
10/08/2021 |
ABCcolla Bone Matrix |
ACRO Biomedical Co., Ltd. |
Dar-Jen Hsieh |
| K212174 |
10/09/2021 |
STERRAD 100NX Sterilizer with ALLClear Technology |
Advanced Sterilization Products, Inc. |
Summer Bowman |
| K202808 |
10/14/2021 |
Brainance MD |
Advantis Medical Imaging Single Member P.C. |
Paris Ziogkas |
| K202688 |
10/14/2021 |
AFS Medical Sterile Single-Use Access Port System |
AFS Medical Co. Ltd. |
Min Ah Kim |
| K210999 |
10/14/2021 |
SwiftMR |
AIRS Medical Inc. |
Jihyeon Seo |
| K213163 |
10/29/2021 |
VersaWrap |
Alafair Biosciences Inc |
Angela Mallery |
| K210563 |
10/15/2021 |
Arm Blood Pressure Monitor |
Alicn Medical Shenzhen,Inc |
Fang Meisong |
| K201520 |
10/27/2021 |
The Alma Opus System, Colibri Applicator and Tips |
Alma Lasers Inc. |
Jessica Rivera-Montejo |
| K211987 |
10/29/2021 |
ATEC Alignment App |
Alphatec Spine, Inc. |
David Gramse |
| K211555 |
10/18/2021 |
Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd |
Bingyi Xiang |
| K212368 |
10/24/2021 |
Surgical Face Mask |
Anhui Tiankang Medical Technology Co., Ltd. |
Zhang Yong |
| K211308 |
10/04/2021 |
INNI-CERA |
Aon Co., Ltd |
Julie Choi |
| K201880 |
10/15/2021 |
MultiSure GK Link Blood Glucose and Ketone Monitoring System |
Apex Biotechnology Corp. |
Lisu Liu |
| K212516 |
10/22/2021 |
IRNF App |
Apple Inc. |
Dachan Kwon |
| K213002 |
10/14/2021 |
SCORPION Portal Vein Access Set |
Argon Medical Devices |
Scott Bishop |
| K212146 |
10/25/2021 |
Arthrex LoopLoc Knotless Suture |
Arthrex, Inc. |
Lai Saeteurn |
| K211214 |
10/14/2021 |
Sterile Hypodermic Needles for Single Use |
Azur Medical Company Inc. |
Di Zhao |
| K211211 |
10/07/2021 |
Sterile syringes for single use with/without needle |
Azur Medical Company Inc. |
Di Zhao |
| K213085 |
10/25/2021 |
Introcan Safety 3 Closed IV Catheter |
B.Braun Medical Inc. |
Tracy Larish |
| K211035 |
10/19/2021 |
U9000 Plus Ultrafilter |
Baxter Healthcare Corporation |
Carina Pforr |
| K211407 |
10/21/2021 |
Belun Ring BLR-100X |
Belun Technology Company Limited |
Leung Lap Wai Lydia |
| K210249 |
10/25/2021 |
Best Glove-Nitrile Powder Free Examination Glove |
Bestsafe Glove CO., LTD |
Piyawat Chirasakulkarun |
| K212082 |
10/06/2021 |
Picore |
Bio-Med USA Inc |
Young Chi |
| K210511 |
10/20/2021 |
InTray GC |
Biomed Diagnostics Incorporated |
John F Antiabong |
| K210287 |
10/28/2021 |
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) |
bioMerieux, Inc |
Cherece L Jones |
| K213264 |
10/29/2021 |
CARTO 3 EP Navigation System Version 7.2 |
Biosense Webster, Inc. |
Khaled Hamad |
| K212593 |
10/15/2021 |
ViaCath, AcQRate Dx Steerable Catheter |
Biotronick, Inc. |
Jon Brumbaugh |
| K212307 |
10/12/2021 |
BC Reflex Uni Knee System |
Bodycad Laboratories, Inc. |
Nadine Adia |
| K203002 |
10/05/2021 |
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System |
Bonebridge AG |
Christof Gerber |
| K212490 |
10/20/2021 |
AVVIGO Guidance System II |
Boston Scientific Corporation |
Margaret Batchelder |
| K201989 |
10/08/2021 |
B4C System |
Braincare Desenvolvimento e Inovacao Tecnologica S.A. |
Arnaldo Betta |
| K212828 |
10/01/2021 |
BRIUS Planner Software |
BRIUS Technologies Inc |
Mehdi Roein-Peiker |
| K213028 |
10/21/2021 |
Tenax Laser Resistant Endotracheal Tube |
Bryan Medical , Inc. |
Andrew J Georgilis |
| K203288 |
10/05/2021 |
Cala Trio |
Cala Health, Inc. |
Amanda Johnston |
| K212793 |
10/25/2021 |
Laser Treatment System, Model: Hera, Armo |
Canadian Pioneer Medical Technology Corporation |
Rashid Reza Mir Sayah |
| K210204 |
10/19/2021 |
Capsule Vitals Plus Patient Monitoring System |
Capsule Technologie SAS |
Peter Kelley |
| K211621 |
10/06/2021 |
Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K212528 |
10/18/2021 |
Change Healthcare Cardiology |
Change Healthcare Israel Ltd. |
Chester McCoy |
| K211719 |
10/06/2021 |
ZinRom Nitrile examination gloves |
Changzhou Xingrong Medical Technology Co. LTD |
Ray Lei |
| K210490 |
10/05/2021 |
ChM 4.5mm Cortical screws |
ChM sp. z o.o. |
Andrzej Sobolewski |
| K210618 |
10/20/2021 |
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series |
Chongqing Jinshan Science & Technology Co., Ltd. |
Qing Xu |
| K212261 |
10/14/2021 |
StrokeSENS LVO |
Circle Neurovascular Imaging, Inc |
Kyle Mayr |
| K212562 |
10/12/2021 |
Idys-C ZP 3DTi |
Clariance, SA |
MΘlody La Porte |
| K212470 |
10/20/2021 |
iRAD |
Claritas HealthTech Pte Ltd |
Devika Dutt |
| K200839 |
10/28/2021 |
APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module |
Clever Culture Systems |
Julie Winson |
| K211526 |
10/21/2021 |
Portable Scalp Cooling System |
Cooler Heads Care, Inc. |
Kate Dilligan |
| K213164 |
10/26/2021 |
Avaira Vitality |
CooperVision. Inc. |
Ahanitha Ashok |
| K212825 |
10/13/2021 |
CoreLink Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K211775 |
10/22/2021 |
Cohitech Organic Cotton Non-Applicator Cottonlock Tampons |
Cotton High Tech S.L. |
Mφriam Carrero |
| K212479 |
10/08/2021 |
Cohitech Reusable Tampon Applicator |
Cotton High Tech S.L. |
Anna Garcia |
| K211019 |
10/28/2021 |
Disposable Monopolar Laparoscopic Tips and Reusable Handles |
Dannik LLC |
Olga Haberland |
| K210231 |
10/14/2021 |
Vittra APS Unique |
Dentscare Ltda |
Roberta Uyara |
| K210911 |
10/19/2021 |
WOLF Thrombectomy System, 14F |
DeVoro Medical, Inc. |
Michael P Wallace |
| K201931 |
10/02/2021 |
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) |
Dixi Medical |
Lucie Petegnief |
| K211374 |
10/13/2021 |
Proclean - Nitrile Powder Free Examination Gloves |
Dr.Boo Company Limited |
Darunee Varabuntoonvit |
| K210140 |
10/01/2021 |
electrocardiograph: SE-1202 |
Edan Instruments, Inc |
Ying Dai |
| K210139 |
10/01/2021 |
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 |
Edan Instruments, Inc. |
Ying Dai |
| K210002 |
10/01/2021 |
STELLA BIO |
EGZOTech Sp. z o. o. |
Michal Mikulski |
| K212270 |
10/21/2021 |
DEKA LipoAI |
EL.EN Electronic Engineering Spa |
Paolo Peruzzi |
| K211091 |
10/15/2021 |
Deka Tiac II |
EL.EN Electronic Engineering Spa |
Paolo Peruzzi |
| K212218 |
10/25/2021 |
Advanced Algorithms for Treatment Management Applications (AATMA) |
Elekta Solutions AB |
Melinda Smith |
| K212114 |
10/01/2021 |
Elekta Unity |
Elekta Solutions AB |
Melinda Smith |
| K210279 |
10/29/2021 |
Enbio S |
Enbio Group AG |
Lukasz Rogowski |
| K211186 |
10/22/2021 |
Erchonia XLR8 |
Erchonia Corporation |
Steven Shanks |
| K211795 |
10/04/2021 |
EzDent-i/ E2/ Prora View/ Smart M Viewer |
Ewoosoft Co., Ltd. |
Young Seok Kim |
| K211927 |
10/12/2021 |
Nitrile examination gloves |
Fitone Latex Products Co., Ltd. Guangdong |
Christine Ou |
| K213195 |
10/29/2021 |
Balloon BS-3 |
FUJIFILM Corporation |
Randy Vader |
| K211171 |
10/21/2021 |
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories |
GE Healthcare Finland Oy |
Joel Kent |
| K210807 |
10/22/2021 |
FlightPlan for Liver |
GE Medical Systems SCS |
Ning Wen |
| K211161 |
10/29/2021 |
Critical Care Suite with Endotracheal Tube Positing AI algorithm |
GE Medical Systems, LLC |
Chris Paulik |
| K201017 |
10/18/2021 |
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit |
GeneOhm Sciences Canada, Inc. (BD Life Sciences) |
Katie Edwards |
| K213081 |
10/26/2021 |
CLISIS SYSTEMS, Discovery RF180 |
General Medical Merate S.P.A |
Luca Bianchessi |
| K212433 |
10/01/2021 |
Anthem Fracture System |
Globus Medical Inc. |
Jennifer Antonacci |
| K211797 |
10/28/2021 |
TRACKER Plus Kyphoplasty System |
GS Medical Co. Ltd. |
Sam Camp |
| K202433 |
10/15/2021 |
Aqueduct 200 Cervical Dilation Balloon Catheter |
GTIMD LLC |
Eran Levit |
| K200558 |
10/04/2021 |
Smart Neck Stimulator |
GUANDONG SKG INTELLIGENT TECHNOLOGY CO., LTD |
Mao Hui Zhang |
| K212078 |
10/08/2021 |
Medical Examination Gloves |
Guangdong Gymda Medical Technology Co., Ltd |
Olivia Chen |
| K210376 |
10/07/2021 |
Superior Hair Remover |
Guangzhou Haoxingwan Technology Co., Ltd. |
Chun Tao |
| K212311 |
10/21/2021 |
Medical Examination Gloves |
Guangzhou Junda Gloves Co., Ltd |
Olivia Chen |
| K201210 |
10/08/2021 |
The Micro Screw System, Micro Screw System Basic |
Hager & Meisinger GmbH |
Simon G÷ddeke |
| K210406 |
10/05/2021 |
Bipolar Coagulation Foreceps |
Hangzhou AGS MedTech Co., Ltd. |
Yanping Fu |
| K212254 |
10/19/2021 |
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) |
HDX Will Corp. |
Kaon Kim |
| K212233 |
10/05/2021 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
James J Rogers |
| K201773 |
10/19/2021 |
PICOHI |
Hironic Co., Ltd. |
Su Yeon Back |
| K193613 |
10/18/2021 |
Allergen-Specific IgE Assay 12 Allergen Bundle |
Hitachi Chemical Diagnostics, Inc. |
Christina Kong |
| K211406 |
10/07/2021 |
OASIS MRI System |
Hitachi Healthcare Americas |
Aaron Pierce |
| K211403 |
10/15/2021 |
HIVOX OTC Electrical Stimulator, FT610-B |
Hivox Biotek Inc. |
Ruby Lu |
| K211509 |
10/24/2021 |
Surgical Gown |
Hubei Wanli Protective Products Co. Ltd |
Andy Wen |
| K211899 |
10/04/2021 |
Surgical Face Mask |
Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD |
Moody Shaw |
| K201394 |
10/05/2021 |
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K212632 |
10/18/2021 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
Larry Boucher |
| K212401 |
10/25/2021 |
Disposable Nitrile Examination Glove |
Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
Guo Hua |
| K203565 |
10/19/2021 |
Surgical 3D Mask |
Inno Lifecare |
Jae Ho Lee |
| K212517 |
10/15/2021 |
Magicore System |
InnoBioSurg Co., Ltd. |
JongHyuk Seo |
| K212967 |
10/15/2021 |
AxTiHA Stand-Alone ALIF System |
Innovasis, Inc. |
Marshall McCarty |
| K211224 |
10/15/2021 |
RM4 Control Unit |
Institut Georges Lopez |
Matthieu Prouteau |
| K203750 |
10/09/2021 |
Straumann CARES P-Series CAD/CAM System |
Institut Straumann AG |
Gordon Dodds |
| K210128 |
10/08/2021 |
INTEGRA Wound Matrix (Macro-Channels) |
Integra LifeSciences Corporation |
Saakshi Arora-Tice |
| K212389 |
10/29/2021 |
Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF |
Intelivation LLC |
Amit Sinha |
| K211121 |
10/14/2021 |
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit |
Intera Oncology, Inc. |
Michael Gaisford |
| K213351 |
10/29/2021 |
ds Head 32ch 3.0T |
Invivo Corporation (Business Trade Name: Philips) |
Sarah Pleaugh |
| DEN190055 |
10/01/2021 |
iotaSOFT Insertion System - Drive Unit, Controller and Accessories |
IotaMotion, Inc. |
Chris Kaufmann |
| K212279 |
10/07/2021 |
Digital Intraoral X-ray Imaging System |
iRay Technology Taicang Ltd. |
Guo Wu |
| K211425 |
10/04/2021 |
Private Stock Labs Surgical Face Mask |
J.K. Private Stock Inc. |
Jonathan Koon |
| K212293 |
10/25/2021 |
Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) |
Jiangmen Ningrui Medical Supplies Co., Ltd. |
Guorong Tan |
| K210270 |
10/01/2021 |
Medical Endoscope Image Processing System |
Jiangsu Jiyuan Medical Technology Co., Ltd. |
Zong Yunfeng |
| K211728 |
10/05/2021 |
Sterile hypodermic syringes for single use |
Jiangsu Kangyou Medical Instrument Co., Ltd. |
Xiang Yao |
| K212036 |
10/05/2021 |
Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs |
Jiangsu Yanfang Medical Technology Co., Ltd. |
Kaijian Wei |
| K210622 |
10/08/2021 |
Single-Use Medical Face Mask |
Jiangxi Hongda Medical Equipment Group Co., Ltd. |
Xiaohua Yang |
| K211753 |
10/14/2021 |
Sterile Syringe With Safety Needle |
Jiangxi Hongda Medical Equipment Group Ltd. |
Xiaohua Yang |
| K212290 |
10/28/2021 |
Examination gloves -Type C (Nitrile gloves) |
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd |
Jenny Huang |
| K212014 |
10/13/2021 |
Medical Nitrile Examination Gloves |
Jiangxi Ronglai Medical Technology Co., Ltd. |
Hailin Shu |
| K210845 |
10/12/2021 |
Disposable Surgical Mask (Model: YYKZ-01) |
Jiaxing Amazing Travel-Ware CO.,LTD |
Jiang Tao |
| K213166 |
10/26/2021 |
Thrombuster II Aspiration Catheter |
Kaneka Medical America LLC |
Audra Bogucki |
| K203497 |
10/08/2021 |
Infrared Thermometer (Model K9) |
Kangzhan Communication Electronics Co., Ltd. |
Su Baotong |
| K203316 |
10/27/2021 |
V.A.C.ULTA Negative Pressure Wound Therapy System |
KCI, a part of 3M Health Care Business Group |
Margaret Marsh |
| K212363 |
10/26/2021 |
Disposable Medical Nitrile Examination Gloves |
Lanhuo Medical Technology (Jiangsu) Co.,Ltd |
Liu Ying |
| K211581 |
10/28/2021 |
Disposable Nitrile Examination Gloves (Powder free, Blue) |
Leping Shengde Medical Technology Company Limited |
Sheng Jianchao |
| K212520 |
10/08/2021 |
ProLift Micro Expandable Spacer System |
Life Spine, Inc. |
Angela Batker |
| K211672 |
10/20/2021 |
MTS Piperacillin-tazobactam 0.016/4 - 256/4╡g/mL |
Liofilchem S. R. L. |
Fabio Brocco |
| K211698 |
10/24/2021 |
Vinyl Examination Gloves(Yellow) |
Liuping Trading CO.,LTD. |
Jing Li |
| K211819 |
10/22/2021 |
DiLumen C2 and Tool Mount |
Lumendi, LLC |
Dennis Daniels |
| K212703 |
10/19/2021 |
AcuPulse CO2 Laser System, Delivery Devices and Accessories |
Lumenis, Ltd. |
Shlomit Segman |
| DEN210005 |
10/20/2021 |
Luminopia One |
Luminopia, Inc. |
Scott Xiao |
| K212876 |
10/08/2021 |
Carescape SpO2 - Masimo |
Masimo Corporation |
Kertana Shankar |
| K212831 |
10/29/2021 |
MectaLIF Extension |
Medacta International S .A. |
Stefano Baj |
| K203808 |
10/20/2021 |
Multi-unit Abutment, Multi-unit Angled Abutment |
MegaGen Implant Co. Ltd. |
You Jung Kim |
| K211405 |
10/04/2021 |
Prelude Guide Sheath |
Merit Medical Systems, Inc. |
David Thomas |
| K210789 |
10/20/2021 |
EQ-PEX |
Meta Systems Co., Ltd. |
Hyejin Park |
| K212403 |
10/30/2021 |
Tracheal Stent System (Y-Shaped) |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K200011 |
10/01/2021 |
E-CLASS« DUAL MOBILITY INSERTS and DYNASTY« DUAL MOBILITY LINERS |
Microport Orthopedics, Inc. |
Kristen Russell |
| K210632 |
10/20/2021 |
Contour ProtegeAI |
MIM Software Inc. |
Lynn Hanigan |
| K211170 |
10/19/2021 |
Single Use Irrigation bipolar cable |
Modern Medical Equipment Manufacturing, LTD. |
Jerry Cheung |
| K211160 |
10/28/2021 |
EndoTool SubQ 2.1 |
Monarch Medical Technologies, LLC |
Ann Marie Gaitan |
| K192746 |
10/19/2021 |
MyoWorx TM20 |
MyoWorx Inc. |
Bert Oucharek |
| K202120 |
10/22/2021 |
P300 Attachment |
Nakanishi Inc. |
Masaaki Kikuchi |
| K211429 |
10/05/2021 |
NAVIPLAN - CT Planning Software for Total Hip Replacement |
Naviswiss AG |
Jan Stifter |
| K212399 |
10/22/2021 |
Aveli |
NC8, Inc. |
Mellissa Viotti |
| K212489 |
10/28/2021 |
BonOs Inject Bone Cement; NEO Pedicle Screw System |
Neo Medical SA |
Jonas Larsson |
| K212396 |
10/22/2021 |
UroLift System Rigid Retrieval Kit Sterilization Tray |
NeoTract, Inc. |
Brian Gall |
| K212908 |
10/13/2021 |
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device |
Neuravi Ltd. |
Niall Fox |
| K212666 |
10/22/2021 |
Neuromark System |
Neurent Medical |
Kenny Walsh |
| K211680 |
10/08/2021 |
Streamline Surgical System |
New World Medical, Inc. |
Victor Arellano |
| K210024 |
10/07/2021 |
NeoMatriX Wound Matrix |
NeXtGen Biologics, Inc. |
Jonelle L. Toothman |
| K210706 |
10/19/2021 |
Nitrile Examination Gloves |
Niujian Technology Co., Ltd. |
Xiuqiang Zhou |
| K210310 |
10/22/2021 |
CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit |
Nuance Medical, LLC |
Neal Hartman |
| K211064 |
10/29/2021 |
nView s1 with nav option |
nView medical |
Lisa Last |
| K210424 |
10/22/2021 |
Quantum Anterior Cervical Plate |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K212544 |
10/13/2021 |
MiniLoad Syringe |
OcuJect, LLC |
Rebecca K Pine |
| K210588 |
10/31/2021 |
Black Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
Freddy Low |
| K211537 |
10/26/2021 |
QuickAligners |
Oral Image, Inc |
Vinh Lam |
| K211807 |
10/14/2021 |
Sapphire NC 24 |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
Daniel Zhang |
| K201312 |
10/04/2021 |
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack |
Ortho Clinical Diagnostics |
Leah Van De Water |
| K213113 |
10/21/2021 |
Orthoscan Tau Mini C-Arm |
Orthoscan, Inc. |
Kevin Bridgman |
| K212560 |
10/12/2021 |
SignatureÖ ONE System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Sankalp Dere |
| K212414 |
10/01/2021 |
OSSDSIGN Cranial PSI |
OssDsign AB |
Ulrik Birgersson |
| K211992 |
10/15/2021 |
Ortho MI System |
Osteonic Co., Ltd. |
Lee Jisun |
| K210873 |
10/27/2021 |
Thermo Scientific Oxoid Lefamulin Disc (20╡g) LMU20 |
Oxoid Limited (part of Thermo Fisher Scientific) |
Philip Brame |
| K212739 |
10/06/2021 |
ActiFlip |
Parcus Medical LLC. |
Calen Souther |
| K211147 |
10/14/2021 |
ALGO 7i |
Path Medical GmbH |
Ing. Johann Oswald |
| K212201 |
10/01/2021 |
PENTAX Medical Auto Leakage Tester SHA-P6 |
PENTAX of America, Inc. |
William Goeller |
| K210928 |
10/21/2021 |
PENTAX Medical Video Bronchoscope EB11-J10 |
PENTAX of America, Inc. |
William Goeller |
| K210177 |
10/20/2021 |
PENTAX Medical Video Upper GI Scopes EG17-J10 |
PENTAX of America, Inc. |
William Goeller |
| K212813 |
10/01/2021 |
Zenition 70 |
Philips Medical Systems Nederland BV |
Swapnil Sharadkumar Jain |
| K210906 |
10/07/2021 |
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 |
Philips Medizin Systeme Boeblingen GmbH |
Monica da Silva |
| K201032 |
10/29/2021 |
Phoenix Digital Thermometer |
Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. |
Ramshankar Ghosh |
| K212200 |
10/22/2021 |
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette |
Plasmapp Co,.Ltd |
LEE Seung Hun |
| K212198 |
10/22/2021 |
Tyvek(R) Roll with CI for STERLINKTM Sterilizer |
Plasmapp Co,.Ltd. |
Lee Seung Hun |
| K212193 |
10/22/2021 |
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
Plasmapp Co., Ltd. |
Seung Hun Lee |
| K200545 |
10/21/2021 |
Legend Pro DMA |
Pollogen, Ltd |
Ayala Kamil |
| K211069 |
10/26/2021 |
EndSnorZ Sleep Appliance |
Prismatik Dentalcraft, Inc. |
Herbert Schoenhoefer |
| K211415 |
10/21/2021 |
GR Splint Resin System |
Pro3dure Medical GmbH |
Frank Gischer |
| K212835 |
10/06/2021 |
AquaBeam Robotic System |
PROCEPT BioRobotics Corporation |
Sara Muddell |
| K212636 |
10/15/2021 |
CORUS Spinal System-X |
Providence Medical Technology, Inc. |
Edward Liou |
| K212205 |
10/14/2021 |
Medical Protective Masks |
Qinhuangdao Taizhi Medical Technology Co., Ltd. |
Fan Xifan |
| K212753 |
10/18/2021 |
0909FCB, 1212FCA |
Rayence Co., Ltd |
Kevin Kim |
| K212065 |
10/07/2021 |
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger |
Remington Medical, Inc. |
Caitlin Senter |
| K211332 |
10/01/2021 |
D Camera Controller |
Richard Wolf Medical Instruments Corporation |
Michael Loiterman |
| K202063 |
10/06/2021 |
TrusFIL Universal Composite Restorative |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K212427 |
10/20/2021 |
cobas Cdiff nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Kaitlyn Hameister |
| K211921 |
10/20/2021 |
S.I.N. Dental Implant System |
S.I.N. - Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K212135 |
10/04/2021 |
Dry DBM- A Putty |
SeaSpine Corporation |
Caryn Sailor |
| K210570 |
10/29/2021 |
TraumaGuard Intra-abdominal Pressure Sensing System |
Sentinel Medical Technologies, LLC |
Robert Mueller |
| K201514 |
10/10/2021 |
Child Face Mask |
Shandong Shengquan New Material Co., Ltd. |
Xiumei Zhang |
| K211084 |
10/19/2021 |
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope |
Shanghai Caremate Medical Device Co. Ltd |
Mark Chu |
| K211604 |
10/27/2021 |
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs |
Shanxi Hongjin Plastic Technology Co., Ltd. |
Wu Zhigang |
| K211564 |
10/19/2021 |
Sterile High-pressure Angiographic Syringes for Single-use |
Shenzhen Boon Medical Supply Co., Ltd |
Baihan Feng |
| K211475 |
10/05/2021 |
Vital Signs Monitors |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Yanhong Bai |
| K211368 |
10/04/2021 |
IPL Hair Remover, Model: G993, G996, G998 and G885 |
Shenzhen Mywin Technology Co., Ltd. |
Meiyun Liu |
| K210813 |
10/08/2021 |
Medical Surgical Mask |
Sichuan Pharmaceutical. Inc. |
Yunrui Zhang |
| K201496 |
10/29/2021 |
N Latex FLC kappa, N Latex FLC lambda |
Siemens Healthcare Diagnostics Products GmbH |
Christine Perkins |
| K212959 |
10/15/2021 |
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter |
Siemens Medical Solutions USA, Inc. |
HyunJung Lee |
| K211221 |
10/01/2021 |
Porous Patella and Porous Tibia Baseplate |
Smith & Nephew, Inc. |
Brad Sheals |
| K213153 |
10/27/2021 |
SPIWay Endonasal Access Guide |
SPIWay, LLC |
Eugene Chen |
| K211801 |
10/13/2021 |
SPRINT PNS System |
SPR Therapeutics, Inc. |
Kathryn Stager |
| K212308 |
10/29/2021 |
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free |
Srirungruang Global Co., LTD. |
Suttichai Sripradub |
| K212424 |
10/28/2021 |
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers |
STERIS Corporation |
Anthony Piotrkowski |
| K212860 |
10/07/2021 |
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) |
Steris Corporation |
Carroll Martin |
| K211508 |
10/05/2021 |
Steinmann Pins and Kirschner Wires |
Stryker GmbH |
Keith Neligan |
| K201934 |
10/01/2021 |
Surgimatix Absorbable Fixation System |
Surgimatix, Inc. |
Dorene Markwiese |
| K210488 |
10/25/2021 |
Ultrasonic Surgical & Electrosurgical Generator |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Guofang Ma |
| K210116 |
10/13/2021 |
Video Endoscopy System, 3D Video Endoscopy System |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Ma Guofang |
| K210562 |
10/01/2021 |
HRSpheres Narrow-Size Embolic Microspheres |
Suzhou Hengrui Hongyuan Medical Co., Ltd. |
Qianqian Zhang |
| K202927 |
10/02/2021 |
EYE-SYNC |
SyncThink, Inc. |
Dan Beeler |
| K213125 |
10/27/2021 |
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology |
Synovis Life Technologies. Inc. (A Subsidiary Of Baxter |
Megan Sajjad |
| K211706 |
10/08/2021 |
Esophageal TTS Stent |
Taewoong Medical Co., Ltd |
Jennifer Moyer |
| K211745 |
10/04/2021 |
RecoveryAir PRO |
Theragun, Inc. |
Jaime Sanchez |
| K213386 |
10/25/2021 |
Titan Manufacturing Bipolar Forceps |
Titan Manufacturing, Inc. |
Donald Seavey |
| K213124 |
10/26/2021 |
Tomier PerformÖ Reversed Glenoid Cannulated Glenospheres |
Tornier, Inc. |
Lisa Stahl |
| K210322 |
10/21/2021 |
XO Cross Support Catheter |
Transit Scientific, LLC |
Jenifer Arnold |
| K213036 |
10/21/2021 |
Treace Medical Concepts (TMC) Screw Fixation System |
Treace Medical Concepts, Inc. |
Kristina Hall |
| K211905 |
10/13/2021 |
UltraCal XS |
Ultradent Products, Inc. |
Adam Black |
| K210124 |
10/19/2021 |
Synergy Gold (SG) Portable (Models MM011450 and MM011460) |
Uzinmedicare Co. |
Nathan Ahn |
| K211461 |
10/14/2021 |
Family of Venus RF Systems - Venus Freedom |
Venus Concept USA Inc. |
Yoni Iger |
| K212552 |
10/12/2021 |
Correx Software |
Vilex LLC |
Louis Monaco |
| K212191 |
10/06/2021 |
Adhesive Electrodes |
Voncare Medical Device Co., Ltd |
Jimmy Zhai |
| K202998 |
10/26/2021 |
Vydence Zye and Vydence One |
Vydence Medical Industria E Comercio Ltda |
Kathy Maynor |
| K212116 |
10/12/2021 |
VBrain-OAR |
Vysioneer Inc. |
Vicki Lin |
| K210348 |
10/24/2021 |
Disposable Medical Surgical Mask |
Weihai Dishang Medical Technology Co., Ltd |
Ricky Xia |
| K202982 |
10/19/2021 |
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) |
Winner Medical Co., Ltd. |
Haoyuan He |
| K201456 |
10/05/2021 |
Scan Monitor |
Withings SA |
Debreuil Xavier |
| K211977 |
10/26/2021 |
Medical Diode Laser Systems |
Wuhan Dimed Laser Technology Co., Ltd. |
Qiao Cheng |
| K211809 |
10/18/2021 |
Surgical Gown |
Wuhan Dymex Healthcare Co., Ltd. |
Lynn Wu |
| K211077 |
10/07/2021 |
Surgical Gown |
Wujiang Tutaike Textiles & Finishing Co., Ltd. |
Zhang Yanwen |
| K203688 |
10/08/2021 |
Clear Aligner |
Wuxi EA Medical Instruments Technologies Limited. |
Yan He |
| K211914 |
10/14/2021 |
Nitrile Patient Examination Gloves |
Yingxiang Glove Products Co., Ltd. |
Liu Peng |
| K211735 |
10/22/2021 |
CO2 Laser Machine, Model: BW-203B |
Zhengzhou Bestview St Co., Ltd. |
Yangchun Jia |
| K212314 |
10/21/2021 |
IPL Hair Removal Device |
Zhongshan Bisen Plastic Electronic Products Co., Ltd. |
Rao Guanhua |
