| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K200908 |
12/22/2020 |
iSMILE |
3D Diagnostix Inc. |
Ehab Amin |
| K200996 |
12/11/2020 |
3M Attest Rapid Readout Biological Indicator |
3M Company |
Mary Fretland |
| K203284 |
12/07/2020 |
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator |
3M Company |
Andrew Wingen |
| K203458 |
12/11/2020 |
3M Comply Hydrogen Peroxide Chemical Indicator 1248 |
3M Company |
Yumi Wackerfuss |
| K203285 |
12/10/2020 |
3M Comply Hydrogen Peroxide Indicator Tape 1228 |
3M Company |
Mary Fretland |
| K202782 |
12/21/2020 |
num Vapocoolant |
623 Medical, LLC |
Ty Schlander |
| K202876 |
12/01/2020 |
Confirm Rx Insertable Cardiac Monitor |
Abbott (St. Jude Medical) |
Juni Sarkar |
| K202330 |
12/07/2020 |
Impella XR Sheath Set |
Abiomed Inc. |
J. Kenneth Ryder |
| K200951 |
12/08/2020 |
Accu-Joint Hemi Implant |
Accufix Surgical, Inc. |
Michael Parisi |
| K203487 |
12/11/2020 |
Drakon and Sequre Microcatheters |
Accurate Medical Therapeutics Ltd |
Osnat Harbater |
| K202412 |
12/18/2020 |
ClearRT Helical kVCT for the Radixact Treatment Delivery System |
Accuray Incorporated |
Keith Picker |
| K203004 |
12/17/2020 |
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System |
ACIST Medical Systems, Inc. |
Jeff Koll |
| K200646 |
12/04/2020 |
TubeClear System |
Actuated Medical, Inc. |
Michael T. Britton |
| K201015 |
12/01/2020 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Serena Sanginthirath |
| K201113 |
12/21/2020 |
Resascope RS-01/B |
Advanced Medical Systems Group SRL |
Francesco Sgarbi |
| K193008 |
12/03/2020 |
Tricoglam Home Use |
Advihair S.R.L. |
Angleo DÆAndrea |
| K192770 |
12/17/2020 |
S dispensing line |
AEA srl |
Michele Mengoni |
| K203461 |
12/18/2020 |
Aesculap Caiman 12 Seal and Cut Technology System |
Aesculap Inc. |
Omunique Luke |
| K202028 |
12/16/2020 |
dermalux Flex MD |
Aesthetic Technology Ltd |
Dale Needham |
| K202229 |
12/22/2020 |
AI Metrics |
AI Metrics, LLC |
Andrew D. Smith |
| K190217 |
12/17/2020 |
Aidite PMMA |
Aidite (Qinhuangdao) Technology Co., Ltd. |
Zhang Wei |
| K203508 |
12/29/2020 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K201167 |
12/03/2020 |
AireHealth NebulizerTM |
AireHealth Inc. |
Rusty Kelly |
| K192709 |
12/15/2020 |
Fixone All Suture Anchor |
AJU Pharm Co.,Ltd. |
Kim Jung Gil |
| K200473 |
12/22/2020 |
SoloAsisst II, Voice Control |
AKTORmed GmbH |
Andreas Mohr |
| K202812 |
12/18/2020 |
IdentiTi Cervical Standalone Interbody System |
Alphatec Spine, Inc. |
Ruby Zheng |
| K203125 |
12/18/2020 |
InvictusÖ OCT Spinal Fixation System |
Alphatec Spine, Inc. |
Ruby Zheng |
| K193646 |
12/04/2020 |
Dynamic Gas Scavenging System 2 (DGSS - 2) |
Anesthetic Gas Reclamation, Inc. |
James Berry |
| K201808 |
12/15/2020 |
X-Tack Endoscopic HeliX Tacking System |
Apollo Endosurgery, Inc. |
Natalie Allen |
| K201776 |
12/30/2020 |
Foley Balloon Catheter for Urology |
Apollon co., Ltd. |
Donghyuk Shin |
| K201489 |
12/22/2020 |
Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set |
Argon Medical Devices, Inc. |
Amy Clendening-Wheeler |
| K203180 |
12/16/2020 |
Arthrex DynaNite Nitinol Staples |
Arthrex Inc. |
Rebecca R Homan |
| K203239 |
12/30/2020 |
Arthrex Low Profile Screws |
Arthrex Inc. |
Samantha Passman |
| K202006 |
12/18/2020 |
ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System |
ArthroCare Corporation |
Jean Asquith |
| K200697 |
12/23/2020 |
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) |
AtriCure Inc. |
Melissa Smallwood |
| K203066 |
12/22/2020 |
COOLIEF Cooled Radiofrequency Kit Advanced |
Avanos Medical, Inc. |
Christian Supina |
| K200346 |
12/17/2020 |
Wrist Type Blood Pressure Monitor |
Avita Corporation |
Amber Dong |
| K200884 |
12/07/2020 |
B-Secur HeartKey Software Library |
B-Secur Ltd. |
David Brown |
| K201469 |
12/09/2020 |
Mini Spike Plus 6/8R |
B. Braun Medical Inc. |
Angela J. Caravella |
| K202706 |
12/31/2020 |
Surgical Gown (Sterile), Surgical Gown (Non-sterile) |
B.J.ZH.F.Panther Medical Equipment CO., LTD. |
Wenyue Han |
| K202069 |
12/01/2020 |
BASE4 Disposable Medical Mask |
Base4 Group, Inc. |
Jon Filipski |
| K201075 |
12/18/2020 |
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter |
Becton, Dickinson and Company |
Kimberly Geisler |
| K202029 |
12/16/2020 |
Medical Surgical Mask |
Beijing Biosis Healing Biological Technology Co., Ltd |
Ting Jiang |
| K200458 |
12/28/2020 |
Tailored-C Cervical Interbody Fusion System |
BeSpoke Technologies |
Daniel Hoehn |
| K200196 |
12/08/2020 |
Taperloc« Complete Hip Stems |
Biomet Orthopedics |
Genoa Atwood |
| K201239 |
12/31/2020 |
NuEra Tight Family, EMS Model |
Bios s.r.l. |
Maurizio Bianchi |
| K202334 |
12/10/2020 |
Neuronaute |
Bioserenity SAS |
Julien Dupont |
| K201865 |
12/08/2020 |
Biomonitor III, Biomonitor IIIm |
Biotronik, Inc. |
Jon Brumbaugh |
| K202026 |
12/18/2020 |
Blue Sky Bio CAD-CAM Abutments |
Blue Sky Bio, LLC |
Michele Kupcso |
| K201919 |
12/17/2020 |
Blue Sky Bio TAD |
Blue Sky Bio, LLC. |
Sharon Nichols |
| K201977 |
12/03/2020 |
TempTraq |
Blue Spark Technologies Inc. |
John Gannon |
| K203162 |
12/18/2020 |
Advanix Biliary Stent with NaviFlex RX Delivery System |
Boston Scientific Corporation |
Elena Hennessey |
| K200404 |
12/03/2020 |
ORISE ProKnife |
Boston Scientific Corporation |
Jennifer Edouard |
| K203257 |
12/23/2020 |
LUBi Water Based Personal Lubricant |
Boya Biotechnology Co., Ltd. |
Jason Lau |
| K201940 |
12/03/2020 |
Braces on Demand Bracket |
Braces on Demand, Inc |
Colin Corey |
| K202320 |
12/23/2020 |
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System |
Brainlab AG |
Cunico Chiara |
| K193419 |
12/27/2020 |
MBT Sepsityper |
Bruker Daltonik GmbH |
Peter Trinder |
| K203437 |
12/22/2020 |
Serranator PTA Serration Balloon Catheter |
Cagent Vascular, LLC |
Carol Burns |
| K201003 |
12/07/2020 |
Callaly Tampliner |
Calla Lily Personal Care, Ltd. |
Shaun Knights |
| K203551 |
12/18/2020 |
Alphenix, INFX-8000V/B, /S, V9.1 |
Canon Medical Systems Corporation |
Paul Biggins |
| K203042 |
12/10/2020 |
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I |
Canon Medical Systems Corporation |
Paul Biggins |
| K203053 |
12/02/2020 |
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Paul Biggins |
| K201250 |
12/18/2020 |
SQuEEZ Software |
Cardiowise, Inc. |
John Coats |
| K203159 |
12/02/2020 |
Lux 35 Detector |
Carestream Health |
Gina Maiolo |
| K202034 |
12/03/2020 |
aprevo Intervertebral Body Fusion Device |
Carlsmed, Inc. |
Mike Cordonnier |
| K202615 |
12/31/2020 |
Nordiwell Medical Face Mask |
Changzhou Combat Protective Equipment Co., Ltd. |
Yanmei Song |
| K200264 |
12/17/2020 |
Exofin High Viscosity Topical Skin Adhesive |
Chemence Medical, Inc. |
Charnelle Thomas |
| K201036 |
12/22/2020 |
PlaniMax Orthodontic Software |
Choice Biotech Inc. |
Tyler Kuo |
| K201643 |
12/22/2020 |
ChoiceSpine Tiger Shark Cervical Spacer System |
ChoiceSpine, LLC |
Kim Finch |
| K201165 |
12/17/2020 |
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath |
Coloplast Corp |
Cori Ragan |
| K203447 |
12/22/2020 |
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement |
Conformis Inc. |
Mary Kruitwagen |
| K202372 |
12/30/2020 |
Upper Arm Electronic Blood Pressure Monitor |
Conmo Electronic Company Limited |
Alice Qi |
| K201980 |
12/18/2020 |
Infrared Thermometer |
Contec Medical Systems Co., Ltd. |
Xueyong Li |
| K202431 |
12/23/2020 |
ControlRad Select Model Z |
ControlRad, Inc |
Chris Fair |
| K202637 |
12/23/2020 |
F3D Corpectomy System |
CoreLink, LLC |
Steven Mounts |
| K202275 |
12/11/2020 |
CorPath GRX System |
Corindus, Inc. |
Dana Hartlein |
| K193159 |
12/30/2020 |
NeuroAmp II, NeuroAmp II.5s |
Corscience gmbH & Co. KG |
Stefan Bolleininger |
| K202701 |
12/07/2020 |
GIA Stapler with Tri-Staple Technology |
Covidien |
Leo Chen |
| K203303 |
12/17/2020 |
Emprint SX Ablation Platform with Thermosphere Technology |
Covidien, LLC |
Liron Bar-Yaakov |
| K202095 |
12/16/2020 |
CreoDent Solidex Customized Abutment and Screw |
CreoDent Prosthetics, Ltd. |
Calvin Shim |
| K202268 |
12/30/2020 |
CrossRoads Tray System |
CrossRoads Extremity Systems, LLC |
Kim Strohkirch |
| K201183 |
12/07/2020 |
Vortex Radial Spray Catheter |
CSA Medical, Inc. |
Heather V Nigro |
| K203016 |
12/05/2020 |
DVT-2600 |
Daesung Maref Co., LTD |
Su Hyeon So |
| K201287 |
12/22/2020 |
Impulse Interbody Fusion System |
DeGen Medical |
Craig Black |
| K202690 |
12/30/2020 |
Remunity Pump for Remodulin (treprostinil) Injection |
DEKA Research and Development |
Paul Smolenski |
| K201458 |
12/23/2020 |
Scrambler Therapy Technology (Model ST-5A) |
Delta International Services & Logistics S.r.l |
Mariella Giorgieri |
| K201707 |
12/22/2020 |
Opallis, Opallis Flow |
Dentscare LTDA |
Roberta Uyara |
| K202248 |
12/28/2020 |
Attune Revision Sleeve LPS Femoral Adaptors |
DePuy Ireland UC |
Erin Combs |
| K203414 |
12/16/2020 |
DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System |
DePuy Synthes |
Stacey Bonnell |
| K200631 |
12/23/2020 |
DeRoyal Temperature Monitoring Probe |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K203097 |
12/16/2020 |
HydroMARK Breast Biopsy Site Markers |
Devicor Medical Products, Inc |
Rhonda M. Kops |
| K200876 |
12/04/2020 |
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System |
Dexcom, Inc. |
Maryam Amini |
| K200857 |
12/17/2020 |
Electric wheelchair (Model: S7012) |
Dongguan Prestige Sporting Goods Co., Ltd. |
Zhang Zhao |
| K202673 |
12/10/2020 |
X-cera Pre-shaded Zirconia Blanks |
Dongguan Xiangtong Co., Ltd. |
Charles Shen |
| K200940 |
12/11/2020 |
BeamSite |
DoseOptics LLC |
Venkat Krishnaswamy |
| K193444 |
12/04/2020 |
Vagisan MoistCream Cremolum |
Dr. August Wolff GmbH & Co. KG Arzneimittel |
Thomas Flototto |
| K202940 |
12/29/2020 |
First Relief v1 |
DyAnsys, Inc |
Srini Nageshwar |
| K203172 |
12/18/2020 |
MOSAIQ Oncology Information System |
Elekta Solutions AB |
Melinda Smith |
| K202588 |
12/07/2020 |
BNA Platform |
elminda, Ltd |
Keren Elghouzzi-Kazachinsky |
| K203026 |
12/23/2020 |
AltiVate« Anatomic Pegged Glenoid with Markers |
Encore Medical, L.P. |
Teffany Hutto |
| K201072 |
12/02/2020 |
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 |
Ensemble Orthopedics, LLC |
Sandie Roth |
| K201996 |
12/21/2020 |
Monocryl Plus Antibacterial Suture |
Ethicon Inc. |
Joice Pappan |
| K202849 |
12/22/2020 |
Everyway Analog OTC TENS, model N103A/N302 |
Everyway Medical Instruments Co., Ltd |
Paul Hung |
| K202835 |
12/02/2020 |
Auryon Atherectomy System |
Eximo Medical Ltd. |
Yoel Zabar |
| K201606 |
12/18/2020 |
LacriJet« |
FCI (France Chirurgie Instrumentation) SAS |
Thierry Fetick |
| K202467 |
12/14/2020 |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads |
Fengh Medical Co., Ltd. |
Jiao Liu |
| K203062 |
12/28/2020 |
Optiflux Series of Dialyzers F160NR, F180NR, F200NR |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K202560 |
12/10/2020 |
AquaPulse Irrigation Tubing |
GA Health Company Limited |
Cindy Ye |
| K202189 |
12/08/2020 |
Graffiti |
GE Medical Systems Information Technologies, Inc. |
Camille Vidal |
| K203137 |
12/29/2020 |
Venue Fit |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K201745 |
12/10/2020 |
Deep Learning Image Reconstruction for Gemstone Spectral Imaging |
GE Medical Systems, LLC |
Katelyn Rowley |
| K202456 |
12/29/2020 |
M5 Recorder |
Global Instrumentation LLC |
Jason DeMaso |
| K200291 |
12/16/2020 |
CREEDÖ Cannulated Screws |
GLW Medical Inc |
Arundhati Radhakrishnan |
| K202211 |
12/22/2020 |
Disposable Medical Surgical Face Masks |
Guangdong Kaidi Garments Co.,Ltd |
MR./MRS. Vicky |
| K202599 |
12/06/2020 |
Transtek Wrist Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Nicole Hu |
| K201658 |
12/11/2020 |
Hamilton-C6 |
Hamilton Medical AG |
Annemarie Weideli |
| K201509 |
12/16/2020 |
Disposable Stone Extraction basket |
Hangzhou AGS MedTech Co., Ltd. |
Chunqi Han |
| K202237 |
12/23/2020 |
Locking device |
Hangzhou AGS MedTech Co., Ltd. |
Yanping Fu |
| K202698 |
12/15/2020 |
Prefilled Syringe |
Hangzhou Primecare Medical Co., Ltd. |
Xueqing Yan |
| K200426 |
12/24/2020 |
Acute Dual Lumen Hemodialysis Catheter |
Health Line International Corporation |
Aaron G. Faulkner |
| K200781 |
12/09/2020 |
Infrared Body Thermometer |
HeiTaiDa Technology Co., Ltd. |
Tom Chen |
| K192073 |
12/23/2020 |
Helix Genetic Health Risk App for late-onset AlzheimerÆs disease |
Helix OpCo, LLC |
Gloria Lee |
| DEN190035 |
12/23/2020 |
Helix Laboratory Platform |
Helix OpCo, LLC |
Gloria Lee |
| K202882 |
12/23/2020 |
Affinity |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K201213 |
12/16/2020 |
Pasteur Pipette 3mL, Pasteur Pipette 1mL |
HertART Aps |
Per Svensson |
| K202384 |
12/02/2020 |
Palm Care Blue Nitrile Examination Gloves Powder Free |
Hi-Care Thai Gloves Co. Ltd. |
Daniel John |
| K202377 |
12/01/2020 |
Palm Care Latex Examination Powder Free Gloves |
Hi-Care Thai Gloves Co. Ltd. |
Daniel John |
| K202337 |
12/15/2020 |
Pulsed electromagnetic field wrap |
Hi-Dow International Inc. |
Eric Chen |
| K201594 |
12/17/2020 |
Primelase Excellence |
High Technology Products SLU |
Sergi Lozano |
| K201747 |
12/27/2020 |
8-CH Electroencephalography Amplifier |
HippoScreen Neurotech Corp. |
William Lan |
| K192970 |
12/01/2020 |
SLIMUS |
HIRONIC Co., Ltd |
Duk Ho Kong |
| K201354 |
12/11/2020 |
TENS & PMS |
Hong Qiangxing (Shen Zhen) Electronics Limited |
Linda Liao |
| K191978 |
12/18/2020 |
Fever Garde |
HuBDIC Co., Ltd. |
Shin Jae-Ho |
| K201185 |
12/18/2020 |
microINR System |
iLine Microsystems S.L. |
Miren Itaso Hormaeche |
| K202485 |
12/25/2020 |
ImPACT Version 4 |
ImPACT Applications, Inc. |
Michael Zagorski |
| K200610 |
12/23/2020 |
Customized Contour Implant |
Implantech Associates Inc. |
Craig Arthur |
| K202345 |
12/18/2020 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordon |
| K201541 |
12/04/2020 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordon |
| K203333 |
12/10/2020 |
Triever20 Curve Catheter |
Inari Medical, Inc. |
Ellen Nguyen |
| K200442 |
12/04/2020 |
InBody |
InBody Co. Ltd. |
Koeun Jung |
| K202418 |
12/03/2020 |
Magic UCLA Abutment System |
InnoBioSurg Co., Ltd. |
Sun-Mi Park |
| K192916 |
12/11/2020 |
NOVA Lite DAPI dsDNA Crithidia luciliae Kit |
Inova Diagnostics, Inc. |
Carolina Auza |
| K200968 |
12/28/2020 |
ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R |
INSUNG MEDICAL CO., LTD. |
Tae-il An |
| K203367 |
12/03/2020 |
LineSiderÖ Spinal System |
Integrity Implants Inc. |
Lauren Kamer |
| K201031 |
12/16/2020 |
NRFit« Caps, Male and Female Neuraxial Tip Caps |
International Medical Industries, Inc. |
David Melly |
| DEN200016 |
12/23/2020 |
EndoRotor Device |
Interscope, Inc |
Jeffery Ryan |
| K202968 |
12/22/2020 |
Da Vinci SP Surgical System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K202834 |
12/10/2020 |
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K202222 |
12/14/2020 |
Irrisept Wound Debridement and Cleansing System |
Irrimax Corporation |
Christy Coleman |
| K202267 |
12/31/2020 |
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles |
Isoray Medical, Inc. |
Leslie White |
| K201754 |
12/30/2020 |
JianYu Surgical Mask |
Jiangsu JianYu Health Medical Co., Ltd. |
Andy Shu |
| K202061 |
12/23/2020 |
Medical Face mask |
Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
Hongfang Tang |
| K201864 |
12/07/2020 |
YUWELL Infrared Thermometer |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
Caixia Yang |
| K201491 |
12/22/2020 |
Neodent Implant System - Zirconia Implant System |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K202270 |
12/02/2020 |
EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device |
K1 Medical LLC |
Jospeh Azary |
| K200965 |
12/29/2020 |
XR-MX/1000 |
KARL STORZ Endoscopy America, Inc. |
Winkie Wong |
| K202925 |
12/17/2020 |
KARL STORZ ICG Imaging System |
KARL STORZ Endoscopy_America, Inc. |
Alita McElroy |
| K202226 |
12/15/2020 |
Lim Precision Steerable TS, Steerable Sheath, Dilator |
Keystone Heart, Ltd. |
Jaime Sarabia |
| K200789 |
12/04/2020 |
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System |
L&K BIOMED Co., Ltd. |
KiHyang Kim |
| K203163 |
12/17/2020 |
ARx Illiac Spinal Screw System |
Life Spine, Inc. |
Angela Batker |
| K201084 |
12/14/2020 |
Physica system |
LimaCorporate S.p.A. |
Michela Zanotto |
| K201905 |
12/17/2020 |
SMR 140░ Reverse Humeral Body |
LimaCorporate S.p.A. |
Giuseppe Valenti |
| K202979 |
12/21/2020 |
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra |
Lode B.V. |
J.R. Fransens |
| K203349 |
12/16/2020 |
Longeviti ClearFit Cranial Implant |
Longeviti Neuro Solutions, LLC |
Jesse Christopher |
| K200549 |
12/16/2020 |
Lucero Medical Cervical Cage System |
Lucero Medical, LLC |
Lee Strnad |
| K203544 |
12/24/2020 |
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories |
Lumenis Ltd. |
Shlomit Segman |
| K201342 |
12/31/2020 |
HANAROSTENT Trachea/Bronchium (CCC) |
M.I. Tech Co., Ltd. |
Inae Kim |
| K202684 |
12/11/2020 |
GMK Total Knee System - TiNbN Coating |
Medacta International SA |
Stefano Baj |
| K202730 |
12/28/2020 |
Quadra-P |
Medacta International SA |
Stefano Baj |
| K203041 |
12/02/2020 |
SMS Cementless Stem |
Medacta International SA |
Stefano Baj |
| K201711 |
12/08/2020 |
CARES Screw - Retained Bars and Bridges (SRBB) |
Medentika GmbH |
Alexandra Schulz |
| K202668 |
12/19/2020 |
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50╡g/dm2 per Glove of Extractable Protein |
Medline Industries, Inc. |
Jennifer Mason |
| K203281 |
12/22/2020 |
Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X |
medPhoton GmbH |
Daniel Schaffarzick |
| K202974 |
12/22/2020 |
DenTek Fresh Protect Dental Guard |
Medtech Products, Inc. |
Vincent Argiro |
| K203291 |
12/08/2020 |
CD Horizon Spinal System Instruments |
Medtronic Sofamor Danek USA, INC. |
Erikka Edwardsen |
| K202623 |
12/08/2020 |
Novapak Nasal Sinus Packing and Stent |
Medtronic Xomed |
Matthew Harmon |
| K202610 |
12/14/2020 |
Ventrax Delivery System |
Merit Medical Systems, Inc. |
Elizabeth Lazaro |
| K201046 |
12/11/2020 |
Automated ankle brachial pressure index measuring device, MESI mTABLET system |
Mesi D.O.O.; Mesi, Development of medical devices, Ltd. |
Jakob Susteric |
| DEN200035 |
12/16/2020 |
BEAR (Bridge-Enhanced ACL Repair) Implant |
Miach Orthopaedics, Inc. |
Martha Shadan |
| K201519 |
12/10/2020 |
PROFEMUR« GLADIATOR« Cemented Classic Stem |
MicroPort Orthopedics Inc. |
Kristen Russell |
| K202837 |
12/04/2020 |
GoSpiro |
Monitored Therapeutics, Inc. |
Michael Taylor |
| K202635 |
12/10/2020 |
MY01 Continuous Compartmental Pressure Monitor |
MY01, Inc. |
Charles Allan |
| K201800 |
12/28/2020 |
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) |
NANORAY Co., Ltd. |
Won Hyun Sung |
| K203452 |
12/22/2020 |
Nano FortiFix« System |
Nanovis LLC |
Matthew Hedrick |
| K200376 |
12/10/2020 |
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration |
Navbit Pty Ltd |
David Thomson |
| K203401 |
12/15/2020 |
Neocis Guidance System (NGS) with Patient Splints (EPS) |
Neocis Inc. |
Thomas E. Claiborne |
| K202264 |
12/04/2020 |
Neocis Guidance System (NGS) with Yomi Plan v2.0 |
Neocis Inc. |
Thomas E. Claiborne |
| K201910 |
12/22/2020 |
EZTrack |
Neurologic LLC |
Sridevi Sarma |
| K202526 |
12/23/2020 |
OmniTom Elite |
NeuroLogica Corporation, a subsidiary of Samsung Electronics |
Ninad Gujar |
| K201495 |
12/14/2020 |
Maxxi Flow Sensor |
Neurovirtual USA, INC. |
Eduardo Faria |
| K202230 |
12/15/2020 |
NEXXT MATRIXX Stand Alone ALIF System |
Nexxt Spine LLC |
Andy Elsbury |
| K203130 |
12/07/2020 |
Ophthalmic Yag Laser System YC-200 |
Nidek Co., Ltd. |
Tsutomu Sunada |
| K202452 |
12/03/2020 |
NobelProcera Zirconia Implant Bridge |
Nobel Biocare AB |
Bernice Jim |
| K200321 |
12/28/2020 |
Novaerus NV1050 |
Novaerus US Inc |
Declan Kiely |
| K202005 |
12/19/2020 |
NovoFine Plus 32G Tip x 4 mm |
Novo Nordisk Inc. |
Hiral Palkhiwala Shah |
| K203249 |
12/04/2020 |
Nucleus.io |
NucleusHealth, LLC |
Zachary Wright |
| K202348 |
12/22/2020 |
External Remote Controller ERC 4P |
NuVasive Specialized Orthopedics, Inc. |
Miriam Cervantes |
| K203253 |
12/03/2020 |
NuVasive ACP System |
NuVasive, Incorporated |
Jessica LeBlanc |
| K200719 |
12/02/2020 |
NuVasive Navigation.S Instruments |
NuVasive, Incorporated |
Adan Alfaro |
| K202657 |
12/14/2020 |
Javelin Tailor's Bunion Fixation System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K203445 |
12/21/2020 |
Trigon HA Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K202661 |
12/08/2020 |
Evis Exera III Duodenovideoscope Olympus TJF-Q190V |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K200342 |
12/17/2020 |
Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K203207 |
12/23/2020 |
Omnia Medical TiBrid-SA |
Omnia Medical, LLC |
Troy Schifano |
| K203090 |
12/11/2020 |
ELEOS Limb Salvage System featuring BIOGRIP |
Onkos Surgical |
Matthew (Matt) Vernak |
| K202231 |
12/10/2020 |
JADE |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
Daniel Zhang |
| K193508 |
12/04/2020 |
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 |
Oxoid Limited (Part of Thermo Fisher Scientific) |
Philip Brame |
| K202699 |
12/29/2020 |
E-Cath STIM acc. Tsui |
PAJUNK GmbH Medizintechnologie |
Christian G.H. Quass |
| K203511 |
12/29/2020 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
Haylie Hertz |
| K202471 |
12/11/2020 |
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft |
PECA Labs |
Doug Bernstein |
| K203166 |
12/30/2020 |
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
PENTAX of America, Inc. |
William Goeller |
| K203383 |
12/15/2020 |
Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 |
Philips Consumer Lifestyle - Innovation Site Eindhoven |
Aurore Millet |
| K201081 |
12/17/2020 |
AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter |
Philips Medical System Nederland B.V. |
Gert De Vries |
| K203087 |
12/03/2020 |
CombiDiagnost R90 |
Philips Medical Systems DMC GmbH |
Supriya Dalvi |
| K200730 |
12/17/2020 |
pjur WOMAN Nude pjur med SENSITIVE glide |
pjur group Luxembourg SA |
Andrea Giebel |
| K200572 |
12/02/2020 |
Planmeca Romexis |
Planmeca Oy |
Lars Moring |
| K201604 |
12/23/2020 |
Plasdent Disposable Barrier Sleeves and Barrier Film |
Plasdent Corporation |
Belen G Walayat |
| K202820 |
12/22/2020 |
Australis Anterior Lumbar Cage System |
Prism Surgical Designs Pty Ltd |
Emma May Young |
| K202681 |
12/31/2020 |
Promisemed Covered Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K193670 |
12/23/2020 |
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set |
Quanta Dialysis Technologies Ltd. |
Chris Rule |
| K203552 |
12/22/2020 |
Rapid Reboot |
Rapid Reboot Recovery Products, LLC |
David Johnson |
| K200374 |
12/14/2020 |
Columbus Guidewire |
Rapid-Medical Ltd. |
Orit Yaniv |
| K202601 |
12/15/2020 |
Single-use Sterile medical laser fiber |
Realton (Suzhou) Medical Technology Co., Ltd |
Mingzhu Liu |
| K203126 |
12/18/2020 |
S10 Kirra |
ResMed Pty Ltd |
Peter Jennings |
| K201039 |
12/07/2020 |
HepaFat-AI |
Resonance Health Analysis Services Pty Ltd |
Alison Laws |
| K201755 |
12/15/2020 |
WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K202565 |
12/02/2020 |
WAVICIDE-OPA MEC Indicator |
Serim Research Corporation |
Jackie Nelson |
| K201284 |
12/14/2020 |
Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use |
Set Medikal Sanayi Ve Ticaret Anonim Sirketi |
Mehice Ozturk |
| K201629 |
12/14/2020 |
Medical Face Mask |
Shandong Shengquan New Material Co., Ltd. |
Xiumei Zhang |
| K202353 |
12/23/2020 |
SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K201735 |
12/14/2020 |
PlaDuo System |
ShenB Co Ltd |
Oskar Lee |
| K202173 |
12/07/2020 |
Pulse Oximeter |
Shenzhen AOJ Medical Technology Co., Ltd. |
Wendy Lin |
| K202324 |
12/14/2020 |
Fingertip Pulse Oximeter |
Shenzhen BSX Technology Electronics Co., Ltd. |
Fang Kai |
| K202827 |
12/15/2020 |
308nm Excimer UV-light Skin Therapy System |
Shenzhen GSD Tech Co., Ltd. |
Zoe Yao |
| K202648 |
12/08/2020 |
Biofeedback Nerve and Muscle Stimulator |
Shenzhen Konmed Technology Co., Ltd. |
Tony No Last Name Provided |
| K200716 |
12/04/2020 |
Electronic Blood Pressure Monitor |
Shenzhen Pango Electronic Co., Ltd. |
Xioyun Yang |
| K201384 |
12/07/2020 |
Pulse Oximeter |
Shenzhen Raysintone Technology CO., Ltd |
Xingbao Yang |
| K203504 |
12/22/2020 |
Cios Flow |
Siemens Medical Solutions USA, Inc. |
Cordell Fields |
| K202322 |
12/31/2020 |
Sim&Size |
Sim&Cure |
Caroline Oziel |
| K202631 |
12/08/2020 |
iHelmet Laser Comb |
Slinph Technologies Co., Ltd |
Jian Zou |
| K201253 |
12/08/2020 |
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation |
Smith & Nephew |
Konrad Wolfmeyer |
| K203540 |
12/23/2020 |
Bridge Occlusion Balloon |
Spectranetics, Inc. |
Sondra Chandler |
| K202298 |
12/22/2020 |
Lucent XP, Lucent XP Curved |
Spinal Elements, Inc. |
Julie Lamothe |
| K200066 |
12/10/2020 |
Posterior Fusion Plate, HA Posterior Fusion Plate |
Spinal Simplicity LLC |
Adam Rogers |
| K203222 |
12/17/2020 |
PERLA TL Posterior Osteosynthesis System |
SPINEART |
Franck Pennesi |
| K203199 |
12/01/2020 |
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector |
STERIS Corporation |
Jennifer Nalepka |
| K201077 |
12/20/2020 |
Strados Remote Electronic Stethoscope Platform (RESP) |
Strados Labs |
Nicholas Delmonico |
| K202659 |
12/01/2020 |
Stryker Arthroscope |
Stryker |
Christie Samsa |
| K202749 |
12/18/2020 |
ADAPT for Gamma3 |
Stryker GmbH |
Ugochi Okereke |
| K202289 |
12/16/2020 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
Jonathan Schell |
| K203219 |
12/29/2020 |
Trevo XP ProVue Retriever and Trevo NXTÖ ProVue Retriever |
Stryker Neurovascular |
Kathy Nguyen |
| K202159 |
12/22/2020 |
actiTENS |
Sublimed |
Corinne Bulteau |
| K202455 |
12/29/2020 |
Aixplorer«MACH20, Aixplorer«MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems |
Supersonic Imagine |
Jacques Souquet |
| K203178 |
12/20/2020 |
Flexitouch Plus System |
Tactile Systems Technology, Inc. (DBA Tactile Medical) |
Brett Demchuk |
| K202454 |
12/28/2020 |
Smart SPACE Shoulder System |
TechMah Medical LLC |
Mohamed R. Mahfouz |
| K200970 |
12/28/2020 |
Self-Contained Biological Indicator |
True Indicating LLC |
Thomas Riha |
| K201317 |
12/04/2020 |
TTBIO EVOCLEAN Ultrasonic Scaler |
TTBIO CORP. |
Sheng-Chieh Su |
| K201555 |
12/18/2020 |
EchoGo Pro |
Ultromics Ltd |
Melissa Clark |
| K203321 |
12/09/2020 |
Cystoject Syringe Lever |
UroGen Pharma Ltd |
James G. Ottinger |
| K203476 |
12/22/2020 |
CAPERE Thrombectomy System |
Vascular Medcure, INC. |
Jeffrey P. DuMontelle |
| K201705 |
12/22/2020 |
ReVene Thrombectomy Catheter |
Vetex Medical, Ltd. |
Mark Bruzzi |
| K202247 |
12/09/2020 |
V30 system, V20 system, V10 system, V-VR Hand piece |
Viora Ltd. |
Simona F Krant |
| K200618 |
12/07/2020 |
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens |
Visco Vision Inc |
Evan Huang |
| K200422 |
12/24/2020 |
Image Quality Analyzer (IQA) |
VisionQuest BioMedical, Inc. |
Gilberto Zamora |
| K202038 |
12/30/2020 |
CryoTreQ |
VitreQ B.V. |
Christian Neele |
| K202388 |
12/01/2020 |
Apolo D / Apolo S |
VMI Tecnologias LTDA |
Siele Santos |
| K202361 |
12/18/2020 |
UltraSlim Digital, UltraSmooth Digital |
Ward Photonics LLC |
Terry Ward |
| K203119 |
12/09/2020 |
ClearPetra Suction-Evacuation Sheath |
Well Lead Medical Co., LTD. |
Jenny Zhu |
| K203467 |
12/23/2020 |
WishBone Medical Plate and Screw System |
WishBone Medical, Inc. |
Mary Wentorf |
| K192308 |
12/21/2020 |
Wu's Electrical Scooter |
Wu's Tech Co., Ltd. |
Jen Ke-Min |
| K201893 |
12/09/2020 |
Disposable Surgical Mask |
Xiamen Probtain Medical Techology Co., LTD |
MR./MRS. Kangjianli |
| K200971 |
12/15/2020 |
308nm Excimer System |
Xuzhou Kernel Medical Equipment Co., Ltd. |
Jing Wang |
| K202983 |
12/08/2020 |
easy Hairfull |
Y&J BIO Co., Ltd. |
Kwang Sic Kim |
| K201712 |
12/01/2020 |
Z5-TL |
Z-Systems AG |
Rubino DiGirolamo |
| K201781 |
12/28/2020 |
Uni-FuZe-P Bone Putty |
Zavation Medical Products, LLC |
Steve Gordon |
| K202487 |
12/04/2020 |
HealthJOINT |
Zebra Medical Vision Ltd. |
Flair Bar |
| K201729 |
12/03/2020 |
Medical Mask |
Zhende Medical Co., Ltd |
Chen Ming |
| K192798 |
12/10/2020 |
Zimmer Segmental System |
Zimmer, Inc. |
Yoriko Kobayashi |
| K202641 |
12/14/2020 |
DNA/RNA Shield Collection Tube |
Zymo Research |
Julie Ogi |
