| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K212081 |
09/05/2021 |
3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 |
3M Company |
Mary Fretland |
| K212320 |
09/28/2021 |
DermatacÖ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring Se |
3M Health Care Business Group |
Teri Feeley |
| K212026 |
09/27/2021 |
Amplatzer Steerable Delivery Sheath |
Abbott Medical |
Dan Gapp |
| K212738 |
09/27/2021 |
Amplatzer Talisman Delivery Sheath |
Abbott Medical |
Daniel Gapp |
| K202092 |
09/23/2021 |
ABC Dental Implant System |
Abracadabra Implants Ltd |
Daniel Younisian |
| K212794 |
09/30/2021 |
Accuray Precision Treatment Planning System |
Accuray Incorporated |
Lizhi Yu |
| K211227 |
09/15/2021 |
HTx Disposable Hysteroscope System |
AcuVu Inc. |
Sam Mostafavi |
| K212421 |
09/03/2021 |
ADAS 3D |
Adas3D Medical S.L |
Antonio Riu |
| K211234 |
09/17/2021 |
RedEx |
Advanced Surgical Concepts ltd |
Edward Hyland |
| K203674 |
09/27/2021 |
B Dispensing Line |
AEA srl |
Michele Mengoni |
| K210160 |
09/10/2021 |
AlertWatch:AC |
AlertWatch, Inc. |
Justin Adams |
| K211805 |
09/22/2021 |
IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System |
Alphatec Spine, Inc. |
Sandy Gill |
| K211762 |
09/03/2021 |
Altor Safety 4-Ply Surgical Mask (Model:62232) |
Altor Safety LLC |
Jared Scott |
| K212757 |
09/30/2021 |
Jada System |
Alydia Health |
Colby Holtshouse |
| K203555 |
09/08/2021 |
AmCAD-UT |
AmCad BioMed Corporation |
Nathan Liu |
| K211740 |
09/29/2021 |
DualX |
Amplify Surgical, Inc. |
Andy Choi |
| K212386 |
09/30/2021 |
AngioVac F18 85 |
AngioDynamics, Inc. |
Kasey E. Newcomb |
| K202885 |
09/15/2021 |
GlucoSure HT Plus Blood Glucose Monitoring System |
Apex BioTechnology Corp. |
Lisa Liu |
| K202049 |
09/07/2021 |
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter |
Applied Medical Resources Corporation |
Andrew Powers Davis |
| K210093 |
09/10/2021 |
AccuFFRangio |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K211074 |
09/02/2021 |
Univers Revers Modular Glenoid System, Standard Augment Baseplates |
Arthrex Inc. |
Ivette Galmez |
| K211479 |
09/16/2021 |
Blue Nitrile Examination Glove Powder Free |
Aspen Glove Sdn. Bhd. |
Iskandar Basha bin Abdul Kadir |
| K211477 |
09/20/2021 |
Latex Examination Powder Free Gloves |
Aspen Glove Sdn. Bhd. |
Iskandar Basha bin Abdul Kadir |
| K211478 |
09/16/2021 |
Sterile Latex Surgical Gloves Powder Free |
Aspen Glove Sdn. Bhd. |
Iskandar Basha bin Abdul Kadir |
| K201305 |
09/03/2021 |
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain |
Atrium Medical Corporation |
Robin Mulvey |
| K210152 |
09/23/2021 |
Automatic Digital Blood Pressure Monitor |
AVICHE Shandong Medical Technology Co, Ltd. |
Zhike Song |
| K210590 |
09/29/2021 |
Axis Spine Technologies ALIF |
Axis Spine Technologies Ltd |
Edwin Lindsay |
| K202618 |
09/24/2021 |
IV Administration Sets |
B. Braun Medical Inc. |
Kimberly Smith |
| K211474 |
09/14/2021 |
Kleiner KG2 System |
Baat Medical Products BV |
Kelsey van Abbema |
| K211097 |
09/22/2021 |
Banyan USA Surgical Mask Level 3 |
Banyan USA LLC |
Ricardo Ryan |
| K203609 |
09/30/2021 |
Intravascular Administration Sets |
Baxter Healthcare Corporation |
Jeffrey E. Thompson |
| K212727 |
09/22/2021 |
FilmArray Pneumonia Panel |
BioFire Diagnostics, LLC |
Kevin Bourzac |
| K202396 |
09/14/2021 |
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) |
bioMerieux, Inc. |
Debra Broyles |
| K212961 |
09/20/2021 |
SMILERS |
Biotech Dental Smilers, SAS |
Delphine Mercier |
| K201445 |
09/02/2021 |
MultiCath, AcQRate Dx Fixed Curve Catheter |
Biotronik, Inc |
Jon Brumbaugh |
| K211579 |
09/07/2021 |
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) |
Bolder Surgical, LLC. |
Nicholas Wong |
| K211375 |
09/10/2021 |
BlazerÖ Dx-20 Bidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
Donall Hosna |
| K211494 |
09/14/2021 |
Polaris X Unidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
Donall Hosna |
| K211158 |
09/17/2021 |
NTI ClenchGuard |
Boyd Research, Inc. |
James Boyd |
| K203155 |
09/17/2021 |
BreatheSuite MDI V1 |
BreatheSuite Inc |
Brett Vokey |
| K211738 |
09/14/2021 |
Rotarex Atherectomy System |
C.R. Bard, Inc. |
Aaron Conovaloff |
| K212708 |
09/23/2021 |
Halo One Thin-Walled Guiding Sheath |
C.R.Bard, Inc |
Annmarie Fitzgerald |
| K212553 |
09/09/2021 |
DIGITAL RADIOGRAPHY CXDI-Pro, D1 |
Canon Inc. |
Akira Hirai |
| K212269 |
09/17/2021 |
Intelligent NR |
Canon Inc. |
Akira Hirai |
| K211828 |
09/10/2021 |
Aquilion Exceed LB |
Canon Medical Systems Corporation |
Paul Biggins |
| K201592 |
09/26/2021 |
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove |
Cardinal Health 200, LLC |
Padmini Sahoo |
| K210586 |
09/14/2021 |
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system |
Cardiovascular Systems Inc. |
Kris Miller |
| K212725 |
09/24/2021 |
ViperCross Support Catheters |
Cardiovascular Systems, Inc. |
Erika Huffman |
| K210951 |
09/01/2021 |
Leonardo Mini Blue |
CeramOptec GmbH |
Roland Dreschau |
| K211667 |
09/23/2021 |
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) |
Changzhou Universal Medical Equipment Co. Ltd |
Jerry Gao |
| K211673 |
09/01/2021 |
Disposable Medical Nitrile Gloves |
Changzhou Yihua Sanitation Material Co., Ltd |
Ding Jie |
| K212246 |
09/09/2021 |
Exofin Precision Pen |
Chemence Medical, Inc. |
Charnelle Thomas |
| K211270 |
09/13/2021 |
CIV-Clear cover |
CIVCO Medical Instruments Co., Inc. |
Jim Leong |
| K203785 |
09/10/2021 |
ClariSIGMAM |
ClariPi Inc. |
Hyun-Sook Park |
| K212136 |
09/29/2021 |
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App |
Cochlear Americas |
Whitney Alexander |
| K202481 |
09/28/2021 |
ThermArt (Model IR-EFT) |
Comper Chuangxiang (Beijing) technology Co., Ltd. |
Han Du |
| K212411 |
09/23/2021 |
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) |
Conformis Inc. |
Kara Johnson |
| K203762 |
09/17/2021 |
Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector |
Covidien |
Ashley Johnston |
| K210402 |
09/09/2021 |
Curiteva Sacroiliac Joint Fusion System |
Curiteva, Inc. |
Eric Linder |
| K210133 |
09/03/2021 |
Current Health Monitoring System Gen 2 (G2) |
Current Health |
Phil Bromley |
| K211637 |
09/03/2021 |
AROMA GRAND |
Daeju Meditech Engineering Co., Ltd. |
Seongun Kim |
| K202395 |
09/01/2021 |
SP-1000, SP-2000 |
DaeSung Maref Co., Ltd |
Hyoung Ju Cho |
| K210523 |
09/30/2021 |
Implanova |
Dental Evolutions Inc. |
Matthew Mineros |
| K210410 |
09/10/2021 |
s-Clean Pre-Milled Abutment Mini |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K212710 |
09/15/2021 |
GLOBAL UNITEÖ Platform Shoulder System |
DePuy Ireland UC |
Yayoi Fujimaki |
| K193650 |
09/14/2021 |
LIAISON Ferritin |
DiaSorin Inc |
John C. Walter |
| K212353 |
09/22/2021 |
DB-EZ Bone Void Filler |
Dimensional Bioceramics, LLC. |
Duran N. Yetkinliner |
| K212491 |
09/02/2021 |
Air Relax Pro Model AR-4.0 |
Diode Art Engineering doing business as Air Relax |
Beomjoon Lee |
| K212328 |
09/26/2021 |
DiscCath Needle Set |
DiscCath LLC |
Gregory E. Lutz |
| K210940 |
09/03/2021 |
LuxaPrint Ortho Plus |
DMG Digital Enterprises SE |
Stephan Schafer |
| K212272 |
09/17/2021 |
Tempo Natural Tampon |
Dong-A Pharmaceutical Co., Ltd. |
Hyunjeong Jang |
| K211583 |
09/03/2021 |
Infrared Thermometer, Model: HW-1 |
Dongguan SIMZO Electronic Technology Co.Ltd. |
Jinlong Wang |
| K212606 |
09/15/2021 |
BeamSite |
DoseOptics LLC |
Venkat Krishnaswamy |
| K210561 |
09/28/2021 |
Advisor Pro Platform |
DreaMed Diabetes Ltd. |
Inbal Beinglass Peled |
| K211856 |
09/10/2021 |
gammaCore Sapphire |
Electrocore, Inc. |
Mike Romaniw |
| K201789 |
09/20/2021 |
CT-STOR |
Energy Delivery Solutions |
William Ehringer |
| K201785 |
09/09/2021 |
EPIEN Dental Cleanser |
EPIEN Medical, Inc. |
Reginald Dupre |
| K201258 |
09/01/2021 |
EASYMAX Tag Self-Monitoring Blood Glucose System |
EPS Bio Technology Corp. |
Iden Chen |
| K212021 |
09/16/2021 |
6430 MyLabX75, 6430 MyLab XPro75 |
Esaote S.p.A. |
Alberto Carcagni |
| K211257 |
09/10/2021 |
EFAI PACS Picture Archiving and Communication System |
Ever Fortune.AI Co., Ltd. |
Chen Ming-Fong |
| K212405 |
09/30/2021 |
EMERGEÖ Anterior Cervical Plate System |
Evolution Spine |
Todd Wallenstein |
| K211700 |
09/28/2021 |
EzDent Web |
Ewoosoft Co., Ltd |
Young Seok Kim |
| DEN200030 |
09/08/2021 |
FEops HEARTguide |
FEops NV |
Sofie Van Cauter |
| K211073 |
09/21/2021 |
Disposable Nitrile Examination Gloves |
Foshan Kangkang Biotechnology Co., LTD |
Yico Xie |
| K203455 |
09/13/2021 |
Disposable Medical Mask |
Fujian Kang Chen Daily Necessities CO., LTD |
Shuyan Wang |
| K210625 |
09/10/2021 |
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve |
FUJIFILM medwork GmbH |
Randy Vader |
| K211488 |
09/10/2021 |
LOGIQ E10 |
GE Healthcare |
Bryan Behn |
| K212067 |
09/17/2021 |
Deep Learning Image Reconstruction |
GE Healthcare Japan Corporation |
Katelyn Rowley |
| K210438 |
09/10/2021 |
Versana Premier |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K203536 |
09/03/2021 |
Male Latex Condom |
Global Protection Corp. |
Christina Cataldo |
| K212334 |
09/21/2021 |
GEO Extremity and Ankle Plating System |
Gramercy Extremity Orthopedics, LLC |
Michael P. Simpson |
| K210868 |
09/02/2021 |
Nitrile Examination Gloves Powder Free (Blue) |
Great Eco Glove Sdn. Bhd. |
Soh Wei Li |
| K212080 |
09/27/2021 |
Imaging Plate Scanner, i-Scan |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Xunxian Wu |
| K211127 |
09/08/2021 |
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM |
Health & Life Co., Ltd |
Peggy Su |
| K212214 |
09/13/2021 |
HandX |
Human Xtensions Ltd. |
Maija Wallenstein |
| K211200 |
09/03/2021 |
WoundExpress |
Huntleigh Healthcare Ltd |
Steve Monks |
| K210726 |
09/29/2021 |
ImmersiveTouch |
ImmersiveTouch, Inc. |
P. Pat Banerjee |
| K212224 |
09/20/2021 |
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform |
Imperative Care Inc. |
Kristin Ellis |
| K210763 |
09/29/2021 |
Inman Digital Clear Aligners |
Inman Orthodontic Laboratories, Inc. |
Donal P. Inman |
| K203799 |
09/20/2021 |
ProFlex CO2 Laser Fiber |
InnovaQuartz LLC |
Stephen Griffin |
| K211276 |
09/15/2021 |
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters |
Innovative Health, LLC. |
Rick Ferreira |
| K212747 |
09/29/2021 |
Da Vinci SP Surgical System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K212227 |
09/30/2021 |
Philips MR Patient Care Portal |
Invivo Corporation |
Maria Keelan |
| K211593 |
09/30/2021 |
Enteral Pump Syringe |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K211904 |
09/17/2021 |
Vinyl Glove |
Jiangsu Dihong Industry and Trade Co., Ltd. |
Sue Chen |
| K211781 |
09/29/2021 |
Disposable Nitrile Gloves |
Jiangsu Jinke Protective Equipment Co., Ltd |
Mia Lai |
| K212009 |
09/15/2021 |
Disposable Nitrile Gloves |
Jiangsu Shenglijie Safety Products Co., Ltd |
Andy Jiang |
| K202796 |
09/06/2021 |
SANSIN Tubing Sets for Hemodialysis |
Jiangxi Sanxin Medtec Co., Ltd. |
Shuiqing Sun |
| K201793 |
09/13/2021 |
EDEN Peek Cage |
JMT Co., Ltd |
Sang-Ok Nam |
| K203014 |
09/01/2021 |
EndoLIF Delta-Cage and DoubleWedge-Cage |
joimax GmbH |
Gary Mocnik |
| K212476 |
09/03/2021 |
KARL STORZ Flexible HD Cysto-Urethroscope System |
KARL STORZ Endoscopy America, Inc. |
Winkie Wong |
| K202056 |
09/10/2021 |
Kinepict Medical Imaging Tool 4.0 |
Kinepict Health Ltd |
Lilla Strobel |
| K212685 |
09/13/2021 |
KONICAMINOLTA DI-X1 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K212287 |
09/21/2021 |
Dayspring Lite |
Koya Medical, Inc. |
Jarren Baldwin |
| K210955 |
09/20/2021 |
Kubtec Mozart Supra (XPERT 84) Radiography System |
KUB Technologies, Inc. |
Chester Lowe |
| K201855 |
09/28/2021 |
Electrically Powered Wheelchair -Model HP358E |
Kunshan Hi-Fortune Health Products Co., Ltd. |
Jianjiang Fan |
| K211201 |
09/02/2021 |
MagnetOs Easypack Putty |
Kuros Biosciences B.V. |
Marcel Borger |
| K210032 |
09/01/2021 |
Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) |
Leadtek Research Inc. |
Kun-Shan Lu |
| K211751 |
09/17/2021 |
WELLTRUST WT-III Mask with Flat Earloop |
Lonestar Meadows LLC |
Karthik Sundaram |
| K212058 |
09/08/2021 |
Longeviti ClearFitÖ OTS Cranial Implants |
Longeviti Neuro Solutions, LLC |
Heather Hourihan |
| K210118 |
09/15/2021 |
INFRARED BODY THERMOMETER (Model: YK-001) |
Longnan RenZhong Medical Equipment Co., Ltd. |
Liangping Liao |
| K211389 |
09/14/2021 |
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation |
Magstim Company Ltd. |
Tom Campbell |
| K210997 |
09/07/2021 |
PreferX Delivery System |
MD3 LLC |
Mary Ann Greenawalt |
| K210263 |
09/22/2021 |
Mpres Neck Preserving Stem |
MEDACTA INTERNATIONAL, SA |
Stefano Baj |
| K210461 |
09/14/2021 |
End Cap |
Medical Components Inc. (Medcomp) |
Patrick McDonald |
| K200898 |
09/21/2021 |
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin |
Medicon Hellas, S.A |
Frank Matuszak |
| K212412 |
09/13/2021 |
IRIS-XP |
Medicore Co., Ltd. |
Kyo-bum Kim |
| K210470 |
09/03/2021 |
C-CURVE Interbody Fusion Device |
Medicrea International S. A. |
Karine Trogneux |
| K211931 |
09/20/2021 |
Medline Digital Thermometer Non-Lubricated Probe Sheath |
Medline Industries, Inc. |
Kelsey Closen |
| K203111 |
09/16/2021 |
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System |
Medtronic |
Kaitlin Cady |
| K212641 |
09/16/2021 |
StrataMR II Valves and Shunts |
Medtronic Neurosurgery |
Swara Vashi |
| K212792 |
09/23/2021 |
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage |
Medynus Inc. |
David Shin |
| K210254 |
09/01/2021 |
MeMed BV |
MeMed Diagnostics Ltd. |
Efrat Hartog-David |
| K202204 |
09/01/2021 |
Tracheal Stent System |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K211973 |
09/24/2021 |
DRI Cocaine Metabolite Assay |
Microgenics Corporation |
Nikhita Tandon |
| K211974 |
09/23/2021 |
LED PHOTIC System |
Micromed S.p.A. |
Nicola Rizzo |
| K202786 |
09/03/2021 |
Dental Low-speed Handpieces and Accessories |
MicroP Technology (Taiwan), Inc. |
Ina Lin |
| K203625 |
09/01/2021 |
Numen Coil Embolization System; NumenFR Detachment System |
MicroPort NeuroTech (Shanghai) Co., Ltd. |
Qiuhua Zou |
| K203722 |
09/02/2021 |
RayPilot System |
Micropos Medical AB |
Thomas Lindstrom |
| K203668 |
09/29/2021 |
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles |
MYCO Medical Supplies, Inc. |
Sanjiv Krumar |
| K212160 |
09/22/2021 |
SimpleSENSE Platform |
Nanowear Inc. |
Venkatesh Varadan |
| K211367 |
09/01/2021 |
Evo sEEG System |
NeuroOne Medical Technologies Corp. |
Joseph Ostendorf |
| K203446 |
09/23/2021 |
TorrentX Wound Wash |
Next Science, LLC |
Courtney Narain |
| K211996 |
09/23/2021 |
Nexta PEEK Hammertoe Correction System |
Nextremity Solutions, Inc. |
Elise Fox |
| K203418 |
09/17/2021 |
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) |
Ningbo Ouhan Medical Device Co., Ltd. |
Annie Annie |
| K203350 |
09/29/2021 |
ENDOtube |
Nissha Medical Technologies SAS |
Roch Mignot |
| K211464 |
09/14/2021 |
Nitta M&T Safety Box |
Nitta M&T (Thailand) Co., Ltd. |
Takumi Moro |
| K212125 |
09/24/2021 |
Nobel Biocare Dental Implant Systems Portfolio - MR Conditional |
Nobel Biocare AG |
Bernice Jim |
| K211769 |
09/07/2021 |
OneLIF Intervertebral Body Replacement System |
NovApproach Spine |
Ronald P. Green |
| K212805 |
09/30/2021 |
SteriCap Mini Needle and Standard Needles |
OcuJect, LLC |
Rebecca K. Pine |
| K201832 |
09/17/2021 |
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K212667 |
09/22/2021 |
Single Use Guide Sheath Kit-401, K-402 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K212643 |
09/27/2021 |
POWERSEAL Curved Jaw Sealer and Divider, Double Action |
Olympus Surgical Technologies America |
Christina Flores |
| K203492 |
09/15/2021 |
Instrument tray, for semi-rigid ureteroscope |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K211972 |
09/01/2021 |
Omeza Collagen Matrix |
Omeza, LLC |
Thomas Gardner |
| K191288 |
09/30/2021 |
Acuitas AMR Gene Panel |
OpGen, Inc. |
Autumn Collasius |
| K211235 |
09/08/2021 |
CIRCUL8 Luxe DVT Prevention Device |
Ortho8 Inc. |
Taylor Nordeen |
| K212303 |
09/21/2021 |
T2 |
Osstem Implant Co., Ltd. |
Jinwoo Bae |
| K210399 |
09/17/2021 |
Unifine SafeControl |
Owen Mumford Ltd |
Darren Mansell |
| K202689 |
09/03/2021 |
Dentilube Spray |
Oxy2plus, LLC |
Chun nan Lin |
| K211334 |
09/10/2021 |
Iovera System |
Pacira Pharmaceuticals Inc. |
Kent Jones |
| DEN200080 |
09/21/2021 |
Paige Prostate |
Paige.AI |
Emre Gulturk |
| K210894 |
09/28/2021 |
SIDDHARTH-II; IMPACT |
Panacea Medical Technologies Pvt.Ltd |
Valli G |
| K212045 |
09/28/2021 |
SoftSpot |
PediaMetrix, Inc. |
Joshua D Levin |
| K212655 |
09/21/2021 |
Flyte |
Pelvital USA, Inc. |
Dale Wahlstrom |
| K202540 |
09/13/2021 |
EliA Rib-P |
Phadia AB |
Carina Magnusson |
| K202541 |
09/13/2021 |
EliA RNA Pol III |
Phadia AB |
Sheryl Skinner |
| K202459 |
09/26/2021 |
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter |
Pharma System AB |
Viljar Salumaa |
| K211597 |
09/08/2021 |
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System |
Philips Medical Systems |
Brenna Loufek |
| K212704 |
09/24/2021 |
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System |
Philips Medical Systems |
Brenna Loufek |
| K212837 |
09/21/2021 |
ProxiDiagnost N90 |
Philips Medical Systems DMC GmbH |
Supriya Dalvi |
| K203845 |
09/17/2021 |
Philips IntelliSite Pathology Solution |
Philips Medical Systems Nederland B.V. |
Liselotte Kornmann |
| K212208 |
09/30/2021 |
Philips IntelliVue GuardianSoftware (Rev. E.0X) |
Philips Medizin Systeme Boeblingen GmbH |
Johannes Schmid |
| K212777 |
09/24/2021 |
Collaboration Live |
Philips Ultrasound, Inc. |
Courtney Nix |
| K212557 |
09/24/2021 |
Virtual C DRF-NEO Digital Imaging System |
Portavision Medical LLC |
Terry Ancar |
| K211242 |
09/09/2021 |
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K210712 |
09/08/2021 |
Verifine Mechanical Safety Insulin Syringe |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K211760 |
09/28/2021 |
Panther OIS |
Prowess Inc. |
Rachel Scarano |
| K212494 |
09/02/2021 |
Lung Image Analysis |
Pulmonx Corporation |
Terry Solomon |
| K210045 |
09/22/2021 |
ACTIVA PRESTO PACK |
Pulpdent Corporation |
Lewis Berk |
| K211352 |
09/09/2021 |
Electronic Thermometer (XHF2001, XHF2002) |
Putian Hanjiang Huafeng Plastic Co., Ltd. |
Yiqian Deng |
| K211867 |
09/08/2021 |
RayStation 11.0 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K212451 |
09/10/2021 |
Surgical Mask |
ReMade USA LLC |
David Durst |
| K212495 |
09/08/2021 |
Leva Pelvic Health System |
Renovia Inc. |
Jim O'Connor |
| K212028 |
09/27/2021 |
Dark Star Navigation Instrument System |
Republic Spine, LLC |
James Doulgeris |
| K201441 |
09/21/2021 |
Elecsys Troponin T Gen 5 |
Roche Diagnostics |
Jane Phillips |
| K210901 |
09/01/2021 |
Elecsys Vitamin D total III |
Roche Diagnostics |
Jamie Ferguson |
| K210385 |
09/09/2021 |
cobas Cdiff nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Gaila Balniene |
| K210509 |
09/09/2021 |
Rocket Platinum Cured Cathter |
Rocket Medical Plc |
Tracy Charlton |
| K202369 |
09/15/2021 |
RXS 1000 |
Rolence Enterprise Inc. |
Ben Chang |
| K211824 |
09/09/2021 |
HERA W9, HERA W10 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Scully Kim |
| K211945 |
09/08/2021 |
V8 Diagnostic Ultrasound System |
Samsung Medison CO., LTD. |
Scully KIM |
| K212139 |
09/01/2021 |
Admiral ACP System |
SeaSpine Orthopedics Corporation |
Cindy Fong |
| K212540 |
09/10/2021 |
Explorer TO System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K212692 |
09/21/2021 |
Mariner Pedicle Screw System |
SeaSpine Orthopedics Corporation |
Jesse Albright |
| K212291 |
09/14/2021 |
PHOENIX |
Sedecal SA |
M¬ Luisa G≤mez de Agⁿero |
| K200639 |
09/29/2021 |
LAP-iX |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K212283 |
09/16/2021 |
BioRoot Flow 0.5g, BioRoot Flow 2g |
Septodont |
Kimty Bui Van |
| K211794 |
09/28/2021 |
Disposable surgical mask |
Shanghai No.9 Knitting Mill Co., Ltd. |
Wang Yipei |
| K211689 |
09/21/2021 |
KEYSTONE PEEK Cage System |
Shanghai Sanyou Medical Co, LTD |
David Fan |
| K212099 |
09/24/2021 |
Red Wave Hair Removal |
Shenzhen Accompany Technology Co., Ltd. |
Yourong Lai |
| K211922 |
09/20/2021 |
IPL Home Use Hair Removal Device |
Shenzhen Beauty Every Moment intelligent electric Co.,Ltd. |
Luo Huajun |
| K211747 |
09/23/2021 |
Reusable NIBP Cuff |
Shenzhen Coreray Technology Co., Ltd. |
Simon Fan |
| K210857 |
09/24/2021 |
Personal Lubricant |
Shenzhen Huanqiu Xuebao Technology Co., Ltd. |
Jiao Li |
| K210441 |
09/17/2021 |
Incontinence Probe |
Shenzhen Med-link Electronics Tech Co, Ltd |
Yongfen Yang |
| K211736 |
09/05/2021 |
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) |
Shenzhen OSTO Technology Company Limited |
Li Yang |
| K211174 |
09/01/2021 |
IPL Hair Removal |
Shenzhen Qiaochengli Technology Co., Ltd. |
LiPing Zhou |
| K210878 |
09/28/2021 |
Surgical Face Mask (Model: CM2006, CM2008, A88) |
Shenzhen RealTone Medical Appliance Co., Ltd. |
Wei Zhou |
| K211305 |
09/14/2021 |
ANNE One |
Sibel Inc. |
Peter Xu |
| K210908 |
09/26/2021 |
Surgical Mask |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K211591 |
09/30/2021 |
NAEOTOM Alpha, Scan&GO |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K212604 |
09/16/2021 |
Symbia VA10A Family |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K211505 |
09/24/2021 |
Encore Hip Stem |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K210707 |
09/23/2021 |
OnGuard2 Chemfort Closed Administration (CADM) |
Simplivia Healthcare LTD. |
Shay Shaham |
| K211439 |
09/30/2021 |
Small Bone Nailing System |
Skeletal Dynamics, Inc. |
Ana M Escagedo |
| K203731 |
09/26/2021 |
DT100 Digital Thermometer |
Smart Technology Co., Ltd. |
Meg Mei |
| K211512 |
09/16/2021 |
VISIONAIRE UK Patient Matched Cutting Guides |
Smith & Nephew, Inc. |
Leah Hawkins |
| K212750 |
09/27/2021 |
Ultrasonic Surgical Aspirator System, Model: XD880B |
SMTP Technology Co., Ltd. |
Songtao Zhan |
| K212660 |
09/22/2021 |
Smylio Invisible Clear Aligners |
Smylio, Inc |
Ren Menon |
| K211935 |
09/30/2021 |
ORIO-Ti Intervertebral Body Fusion Cage System |
SpineCraft, LLC |
Ami Akallal-Asaad |
| K212728 |
09/23/2021 |
Standard Bougie, 38 Fr. and Hand Pump |
Standard Bariatrics |
Michelle Schnell |
| K210342 |
09/03/2021 |
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor |
STERIS Corporation |
Carroll Martin |
| K211607 |
09/07/2021 |
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 |
| K210861 |
09/03/2021 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
Jonathan Schell |
| K211964 |
09/28/2021 |
SubtlePET |
Subtle Medical, Inc. |
Ajit Shankaranarayanan |
| K211296 |
09/11/2021 |
Surgical face mask |
Sunsmed Protective Products Ltd. |
Joyce Lee |
| K202790 |
09/17/2021 |
Syntec Orthodontic Mini Screw Extended System |
Syntec Scientific Corporation |
Nicole Tseng |
| K212108 |
09/24/2021 |
Dynamic TiBase |
Talladium Espa±a, SL |
Xavier Soca Filella |
| K211236 |
09/27/2021 |
Disposable Vinyl Examination Gloves |
Tangshan Hongyun Healthcare Products Co., Ltd. |
Suying Le |
| K210294 |
09/23/2021 |
One Touch Spiral Condom |
Thai Nippon Rubber Industry Public Company Limited |
Ryosuke Takamiya |
| K211450 |
09/30/2021 |
Playboy 3 Contour Condom |
Thai Nippon Rubber Industry Public Company Limited |
Tossaporn Nilkhamhang |
| K212238 |
09/29/2021 |
TheraFace Microcurrent |
Theragun, Inc. |
Jaime Sanchez |
| K210396 |
09/13/2021 |
Harmony Referral System |
Topcon Healthcare Solutions EMEA Oy |
Ramya Sundaram |
| K212556 |
09/15/2021 |
mi-eye 3 needlescope with cannula, mi-tablet 3 |
Trice Medical, Inc. |
David Vancelette |
| K203649 |
09/15/2021 |
TruAbutment DS, TruBase |
TruAbutment Inc. |
Eunjin Jang |
| K210513 |
09/29/2021 |
UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 |
Universal Incorporation |
Mei-Hui Huang |
| K203141 |
09/17/2021 |
Uramix CuraWay Biopsy Needle |
Uramix, Inc. |
Michael Mooreville |
| K210818 |
09/15/2021 |
TrueCare Biomedix Tamper Evident Cap |
US Infusion Inc. D/B/A Truecare Biomedix-USA |
Abbey Kramarz |
| K211881 |
09/02/2021 |
AI Segmentation |
Varian Medical Systems, Inc. |
Peter Coronado |
| K201612 |
09/02/2021 |
Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 |
Viramal Limited |
Simona Fiore |
| K212321 |
09/23/2021 |
JiveX (Model Number / Release: 5.3) |
Visus Health IT GmbH |
Axel Schreiber |
| K212678 |
09/14/2021 |
Viveve System, Viveve 2.0 System |
Viveve Medical, Inc. |
Kevin Robison |
| K210772 |
09/22/2021 |
3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) |
VR Vertical LLC dba XRGO |
Matthew DiPalma |
| K212742 |
09/16/2021 |
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating |
Waldemar Link GmbH & Co. KG |
Lydia Ditter |
| K203434 |
09/08/2021 |
BlueStar Rx |
WellDoc, Inc |
Sabyasachi Roy |
| K211823 |
09/01/2021 |
Bonine Acupressure Bands |
WellSpring Pharmaceutical Corporation |
Renee Davis Grandchamp |
| K211536 |
09/01/2021 |
Welspun Health Surgical Mask |
Welspun India Limited |
Satyapriya Dash |
| K210184 |
09/14/2021 |
Wilson Tech Disposable Medical Face Mask |
Wilson Tech (International) Limited |
Ho Hang Terry Ting |
| K211283 |
09/14/2021 |
Compressible Limb and Circulation Therapy System, Model POWER-Q2300 |
Wonjin Mulsan Co., Ltd. |
Ha Yong Jung |
| K210440 |
09/20/2021 |
Disposable Sampler Inactivated Transport Media, Nest ITM |
Wuxi Nest Biotechnology Co., Ltd. |
Cheng Zhiwei |
| K203112 |
09/16/2021 |
Disposable Medical Mask |
Yangzhou Runyi Arts & Crafts CO., LTD. |
Li Yu |
| K203662 |
09/23/2021 |
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 |
Yibin Junxin Electronics Technology Co., Ltd. |
Chaoze Guan |
| K200423 |
09/22/2021 |
Electric Wheelchair (XW-LY001) |
Yongkang Dingchang Industry & Trade Co., LTD. |
Tony Chen |
| K212002 |
09/23/2021 |
Synthetic Vinyl Examination Gloves |
Yunnan Huazhiyuan Medical Technology Co., Ltd. |
Yun Gao |
| K210085 |
09/15/2021 |
HealthCCSng |
Zebra Medical Vision Ltd. |
Shlomit Cymbalista |
| K210232 |
09/23/2021 |
Sterile Hypodermic Needles for Single Use |
Zhejiang Kangkang Medical-Devices CO., Ltd. |
Chun Guo |
| K210227 |
09/10/2021 |
Sterile syringe for single use with/without needle |
Zhejiang Kangkang Medical-Devices CO., Ltd. |
Chun Guo |
| K211832 |
09/08/2021 |
Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask |
Zhejiang Lanhine Medical Products LTD |
Jerry Gu |
| K211827 |
09/23/2021 |
Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) |
Zhejiang Lanhine Medical Products LTD |
Jerry Gu |
| K211778 |
09/02/2021 |
Nitrile Examination Gloves, Green/ Blue/ Black Color |
Zhenjiang SuHui Latex Products Co., Ltd. |
Zhengfu Sun |
| K212226 |
09/29/2021 |
DR Safety Syringe, Sterile Hypodermic needle for Single use |
Zhuhai DR Medical Instruments Co., Ltd |
Xu Jianhai |
| K212342 |
09/23/2021 |
ZIIP+ Device |
ZIIP, Inc |
David Mason |
| K212129 |
09/28/2021 |
Persona« Personalized Knee System |
Zimmer Switzerland Manufacturing GmbH |
Thomas Lincoln |
