| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K202465 |
11/25/2020 |
Night Guard |
3D Diagnostix Inc. |
Ehab Amin |
| K193432 |
11/09/2020 |
Vantage PSI System |
3D Systems |
Kim Torluemke |
| K202888 |
11/23/2020 |
Confirm Rx Insertable Cardiac Monitor |
Abbott (St. Jude Medical) |
Laura Sparks |
| K202066 |
11/25/2020 |
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled |
Abbott Medical |
Alyssa Timmers |
| DEN190047 |
11/24/2020 |
CADScor System |
Acarix A/S |
Mette Munch |
| K193509 |
01/17/2020 |
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX |
Acutus Medical, Inc. |
Greg Geissinger |
| K191186 |
01/25/2020 |
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode |
Ad-Tech Medical Instrument Corporation |
Lisa Theama |
| K193359 |
01/03/2020 |
SureMAX Family of Cervical Spacers |
Additive Implants, Inc |
Jeff Horn |
| K193287 |
11/20/2020 |
CorInsights MRI |
ADM Diagnostics, Inc. |
Dawn C. Mathews |
| K192581 |
01/28/2020 |
The NightBlocks Appliance |
Advanced Facialdontics LLC |
Scott Simonetti |
| K192025 |
01/23/2020 |
STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader |
Advanced Sterilization Products (ASP) |
Elsie Kim |
| K201902 |
11/05/2020 |
MammaPrint |
Agendia Inc. |
Marcelo Trevino |
| K192618 |
11/02/2020 |
e-Motion M25 |
Alber GmbH |
Michael Vent |
| K201985 |
11/12/2020 |
KardiaAI |
AliveCor, Inc. |
Saket Bhatt |
| K191406 |
01/24/2020 |
KardiaMobile, KardiaStation |
AliveCor, Inc. |
Saket Bhatt |
| K200886 |
11/10/2020 |
StimSite |
Allotrope Medical Inc |
Albert Huang |
| K191739 |
01/02/2020 |
Sterile LeadConfirm |
Alpha Omega Engineering Ltd. |
Maysana Mousa |
| K202587 |
11/06/2020 |
ATEC Lateral Interbody System |
Alphatec Spine, Inc. |
Sandy Gill |
| K203056 |
11/23/2020 |
InvictusÖ Spinal Fixation System |
Alphatec Spine, Inc. |
Cynthia Dorne |
| K190306 |
01/17/2020 |
AMD Ritmed AssureWear VersaGown |
AMD Medicom Inc. |
Ronald Reuben |
| K200334 |
11/12/2020 |
AN1036 Dosimeter |
Andersen Sterilizers, Inc. |
William K Andersen |
| K192980 |
11/12/2020 |
EOGas 4 Endo-SteriTest |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K192978 |
11/12/2020 |
EOGas 4 Ethylene Oxide Gas Sterilizer |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K200335 |
11/12/2020 |
Sterisheet Sterilization Wrap |
Andersen Sterilizers, Inc. |
William K Andersen |
| K200336 |
11/12/2020 |
Tyvek Sterilization Pouches with Chevron Seal |
Andersen Sterilizers, Inc. |
William K Andersen |
| K191642 |
01/06/2020 |
TK Sterile Piston Syringe without Needle |
Anhui Tiankang Medical Technology Co.,Ltd. |
Bai Baodong |
| K190956 |
01/30/2020 |
SCS 17-01 |
Anika Therapeutics, Inc. |
Jeffrey Cyr |
| K202777 |
11/17/2020 |
VeriFixxÖ Small Bone Implant |
Armis Biopharma, Inc. |
Franklin Okumu |
| K203100 |
11/20/2020 |
Arthrex Eclipse Titanium Humeral Head |
Arthrex Inc. |
David L Rogers |
| K202535 |
11/18/2020 |
Arthrex FastThread Interference Screw |
Arthrex Inc. |
Jessica L. Singelais |
| K203268 |
11/27/2020 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Jessica L Singelais |
| K193503 |
01/15/2020 |
Arthrex SwiveLock Suture Anchor |
Arthrex Inc. |
Jessica L. Singelais |
| K202581 |
11/04/2020 |
Arthrex TightRope II |
Arthrex Inc. |
Kelsey N. Roberts |
| K202444 |
11/17/2020 |
Knotless TensionTight Button Implant System |
Arthrex Inc. |
Jessica Singelais |
| K193372 |
01/10/2020 |
Univers Revers Modular Glenoid System (Augemented baseplates) |
Arthrex Inc. |
Ivette Galmez |
| K192599 |
01/02/2020 |
ASAHI PTCA Guide Wire ASAHI Gaia Next |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K183074 |
01/11/2020 |
TENS and EMS Stimulator, TENS Stimulator |
Astek Technology Ltd. |
You-Jhe Lin |
| K191989 |
01/29/2020 |
WVSM (Wireless Vital Signs Monitor) RWC + miniCap |
Athena GTX |
Sean Mahoney |
| K192357 |
01/16/2020 |
INNOVO |
Atlantic Therapeutics Ltd. |
Anne-Marie Keenan |
| K181089 |
01/17/2020 |
SureLead Cable System |
Authentic Medical |
Ricky Souza |
| K201687 |
11/30/2020 |
Avenda Health Treatment System |
Avenda Health, Inc. |
Brittany Berry-Pusey |
| K203106 |
11/10/2020 |
Nio Fusion 12MP (MDNC-12130) |
Barco NV |
Julie Vandecandelaere |
| K192363 |
01/09/2020 |
Altapore |
Baxter Healthcare Corporation |
Phillip Romei |
| K201867 |
11/19/2020 |
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System |
Baxter Healthcare Corporation |
Brad Roynon |
| K193137 |
01/08/2020 |
EASYGRIP FLO-41 Precision MIS Delivery System |
Baxter Healthcare Corportation |
Jeanette Licata |
| K201404 |
11/20/2020 |
Passio Pump Drainage System |
Bearpac Medical |
Jay Zimmerman |
| K202343 |
11/16/2020 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ╡g/mL ) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K193190 |
11/09/2020 |
BD PureHub Disinfecting Cap |
Becton, Dickinson and Company |
Samhitha Mohan |
| K192493 |
01/24/2020 |
BD Cathena (TM) Safety IV Catheter |
Becton, Dickinson Infusion Therapy Systems, Inc. |
Henry Boland |
| K190871 |
01/17/2020 |
Bio-TackS Orthodontic Mini Implant |
Bio Cetec Co., Ltd. |
Hee Sue Jin |
| K192774 |
01/07/2020 |
BioCardia 8F Morph DNA Deflectable Guide Catheter |
BioCardia |
Patrick Lee |
| K192234 |
01/31/2020 |
ActiPatch |
BioElectronics Corporation |
Sree N. Koneru |
| K200239 |
11/13/2020 |
Astroglide Organix Gel |
BioFilm Inc. |
Richard Hines |
| DEN200043 |
11/20/2020 |
FilmArray Global Fever Panel |
BioFire Defense, LLC |
Cynthia Phillips |
| K202382 |
11/20/2020 |
FilmArray Global Fever Panel External Control Kit |
BioFire Defense, LLC |
Cynthia Phillips |
| K192942 |
01/16/2020 |
ALLthread Titanium Suture Anchor |
Biomet Inc. |
Saveetha Raghupathi |
| K193092 |
01/02/2020 |
TunneLoc Tibial Fixation Device |
Biomet Inc. |
Haley Pioch |
| K193214 |
11/10/2020 |
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws |
Biomet Inc. |
Janine Kem |
| K192397 |
01/30/2020 |
TruDi Navigation System |
Biosense Webster |
David Locke |
| K200484 |
11/25/2020 |
CARTO« 3 EP Navigation System with Signal Processing Unit |
Biosense Webster, Inc. |
Khaled Hamad |
| K191330 |
01/31/2020 |
Arc Enterocuff |
Boddingtons Plastics Ltd |
Shimaa Elsawy |
| K191538 |
01/16/2020 |
Resectr Tissue Resection Device |
Boston Scientific Corporation |
Brooke Cuddy |
| K191446 |
01/02/2020 |
Ureteral Stent Systems, Biliary Drainage Catheters |
Boston Scientific Corporation |
Jois Zuniga Gamboa |
| K181005 |
01/15/2020 |
ClenchGuard |
Boyd Research, Inc. |
James Boyd |
| K191014 |
01/23/2020 |
Elements Viewer |
Brainlab AG |
Oliver Fleig |
| K203173 |
11/12/2020 |
ExacTrac Dynamic |
Brainlab AG |
Chiara Cunico |
| K200761 |
11/25/2020 |
Tenax Laser Resistant Endotracheal Tube |
Bryan Medical, Inc. |
Andrew J. Georgilis |
| K202150 |
11/18/2020 |
GlidePath 7.5F Long-Term Dialysis Catheter |
C.R. Bard, Inc. |
Joan Bergstrom |
| K201568 |
11/12/2020 |
Calvary Spine Pedicle Screw System |
Calvary Spine, LLC |
James Edwards |
| K192715 |
01/07/2020 |
CRF Radiofrequency Ablation System |
Cambridge Interventional LLC |
Michael A. Arnold |
| K201904 |
11/24/2020 |
Monet Curing Laser |
CAO Group, Inc. |
Robert K. Larsen |
| K193270 |
01/31/2020 |
CapLOX II«/TowerLOX« MIS Pedicle Screw System |
Captiva Spine, Inc. |
George Chaux |
| K203317 |
11/25/2020 |
CarboClear X Pedicle Screw System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K203008 |
11/19/2020 |
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
Nikita Basabdra |
| K193574 |
01/22/2020 |
Q-Rad System |
Carestream Health, Inc. |
Carolyn L Wagner |
| K202442 |
11/19/2020 |
Carewear Firefly Wrinkle Reduction |
Carewear Corp. |
Patrick Parker |
| K192251 |
01/15/2020 |
Livento Press, Soprano 10, Soprano |
Cendres+Metaux SA |
Andrea Sparti |
| K201742 |
11/24/2020 |
eKuore One Wireless Electronic Interface for stethoscope |
Chip Ideas Electronics S.L |
Bernardo Plaza Trillo |
| K190954 |
01/22/2020 |
Fundus Camera |
Chongqing Bio NewVision Medical Equipment Ltd. |
Wang Hao |
| K201308 |
11/27/2020 |
Axonpen, Axonmonitor, Axonbox, Tablet |
ClearMind Biomedical |
Sheng-Chi Lin |
| K200820 |
11/13/2020 |
SpeediCath Compact Set |
Coloplast |
Michael Bumgarner |
| K192904 |
11/02/2020 |
SpeediCath Compact Set |
Coloplast |
Michael Bumgarner |
| K202713 |
11/18/2020 |
TrueView 100 Pro |
CompAI Healthcare (Shenzhen) Co.,ltd |
Wang Yan |
| K202074 |
11/12/2020 |
Apache Ultrasound System (Model C62) |
Compal Electronics, Inc. |
DK Lee |
| K193637 |
01/28/2020 |
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System |
Compania Mexicana De Radiologia CGR, S.A. DE C.V. |
Tonatiuh Monroy Soberon |
| K193606 |
01/22/2020 |
Y-Knot OneStep Anchor |
ConMed Corporation |
Carrie Engleman |
| K203179 |
11/20/2020 |
Fortress Introducer Sheath System |
Contract Medical International GmbH |
Marketa Shanelova |
| K191498 |
01/29/2020 |
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc |
Cook Incorporated |
Carly Powell |
| K191020 |
01/14/2020 |
G210 InviCell Plus with SignipHy pH monitoring |
CooperSurgical Inc. |
Kyle Hooper |
| K201060 |
11/16/2020 |
Cordiana Dx16 |
Cordiana Medical Informatics AG |
Johan Sandberg |
| K202805 |
11/20/2020 |
Optimized Positioning System (OPS) Insight |
Corin USA |
Lucinda Gerber |
| K191831 |
01/16/2020 |
MobiliT Cup |
Corin USA Limited |
Severine Siracusa |
| K201881 |
11/13/2020 |
CoroFlow Cardiovascular System |
Coroventis Research AB |
Johan Svanerud |
| K192330 |
01/23/2020 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Sarah Tang |
| K192302 |
01/17/2020 |
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter |
Covidien, llc |
Carol S Ming |
| K193056 |
11/20/2020 |
Puritan Bennett 980 Series Ventilator System |
Covidien, LLC |
Zheng Liu |
| K193452 |
01/10/2020 |
MotoBAND CP Implant System |
CrossRoads Extemity Systems, LLC |
Kim Strohkirch |
| K203187 |
11/18/2020 |
HiRise |
CurveBeam, LLC |
Ryan Conlon |
| K192497 |
01/06/2020 |
EVOL ha - D Lateral Interbody Fusion System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K201382 |
11/18/2020 |
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) |
de Gotzen S.r.l. |
Dario Bandiera |
| K192412 |
01/06/2020 |
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece |
DentalEZ, Inc. |
Robert Young |
| K192436 |
01/23/2020 |
Healing Abutments and Cover Screws |
Dentium Co., Ltd. |
Byung-sun Kim |
| K192409 |
01/13/2020 |
Midwest Rhino XE and Air Motor M |
Dentsply Sirona |
Karl Nittinger |
| K192530 |
01/23/2020 |
Surefil one Self-adhesive Composite Hybrid |
Dentsply Sirona |
Karl Nittinger |
| K193057 |
01/30/2020 |
ATTUNE All-Polyethylene Tibia |
DePuy Ireland UC |
Kathy Harris Brocato |
| K202194 |
11/25/2020 |
ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUMÖ 3DP Technology |
DePuy Ireland UC |
Erin Combs |
| K202098 |
11/25/2020 |
GLOBAL UNITEÖ Platform Shoulder System |
DePuy Ireland UC |
Karen Mahoney |
| K203167 |
11/19/2020 |
DePuy Corail AMT Hip Prosthesis |
DePuy Orthopaedics Inc. |
Erin Combs |
| K191425 |
01/21/2020 |
Hydro-Temp Neonatal Skin Temperature Probe Cover |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K200461 |
11/16/2020 |
Freeprint denture |
Detax GmbH & Co. KG |
Markus Stratmann |
| K193642 |
01/29/2020 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Linda Wang |
| K193051 |
01/29/2020 |
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set |
DiaSorin Inc. |
John C. Walter |
| K201653 |
11/27/2020 |
Compex Sport Elite 3.0 |
DJO, LLC |
Michael Davis |
| K192920 |
01/14/2020 |
Oragene«òDx |
DNA Genotek Inc. |
Austin Udocor |
| K203287 |
11/18/2020 |
DBSWIN, VISTAEASY |
Dⁿrr Dental SE |
Oliver Lange |
| K193621 |
11/23/2020 |
Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) |
Dongguan E-Test Technology Co., Ltd |
Victor Wan |
| K201815 |
11/20/2020 |
Dornier MAGELLAN Ureteral Access Sheath |
Dornier MedTech America Inc |
John Hoffer |
| K201937 |
11/13/2020 |
Ceramir Restore QuikCap |
Doxa Dental AB |
Anna-Lisa Tiensuu |
| K200077 |
11/06/2020 |
BioMin Restore Plus |
Dr. Collins, Inc. |
Jiahe Li |
| K200005 |
11/09/2020 |
Concinnity Aligners |
Drake Precision Dental Laboratory Inc |
Robert Savage |
| K200580 |
11/19/2020 |
FotoDent denture |
Dreve Dentamid GmbH |
Reiner Altmann |
| K191221 |
01/10/2020 |
Cybird LED Curing Light |
DXM Co., Ltd |
Seung Hyun Kim |
| K192564 |
01/21/2020 |
Disposable Gold Cup EEG Electrodes |
Dymedix Diagnostics, Inc. |
Todd Eiken |
| K190837 |
01/22/2020 |
Internal Hex Implant System |
EBI Inc. |
DongJun Yang |
| K200017 |
11/05/2020 |
Eclipse DermaFlex Cannula |
Eclipse MedCorp, LLC |
John Tepper |
| DEN190029 |
11/13/2020 |
Acumen Assisted Fluid Management (AFM) Software Feature |
Edwards Lifesciences |
Lisa Gilman |
| K192889 |
01/30/2020 |
Neo |
eemagine Medical Imaging Solutions GmbH |
Maarten Van De Velde |
| K191937 |
01/29/2020 |
Ezvena IPC, Ezvena SQS |
Eezcare Medical Corp |
Michelle C Mitchell |
| K191147 |
01/02/2020 |
OC-Auto SENSOR io iFOB Test |
Eiken Chemical Co., Ltd. |
Tadashi Yasuda |
| K192004 |
01/15/2020 |
Eko Analysis Software |
Eko Devices Inc |
Connor Landgraf |
| K202079 |
11/25/2020 |
Physiq |
El. En. Electronic Engineering SPA |
Paolo Peruzzi |
| K202558 |
11/02/2020 |
Ellusa Bipolar Wands |
Ellusa, LLC |
Suzanne Lucas |
| K202562 |
11/02/2020 |
Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set |
Ellusa, LLC |
Suzanne Lucas |
| K192457 |
01/02/2020 |
Elos Accurate Customized Abutment |
Elos Medtech Pinol A/S |
Tina Friis Poulsen |
| K192170 |
01/23/2020 |
VistaScan USB Ultrasound Imaging System |
Emagine Solutions Technology, LLC |
Courtney Williams |
| K203085 |
11/12/2020 |
NOVA Patient Warming System |
Encompass Group, LLC |
Eric Howard |
| K191254 |
01/30/2020 |
EndoClot |
EndoClot Plus Co., Ltd. |
Hendry Zhang |
| K201173 |
11/27/2020 |
E-Guard |
EnvisionTEC GmbH |
Ruediger van Bernum |
| K190669 |
01/03/2020 |
Endotics |
Era Endoscopy s.r.l. |
Alberto Arena |
| K190651 |
01/07/2020 |
ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter |
Erbe Elektromedizin GmbH |
Julia Weller |
| K192544 |
01/13/2020 |
Erchonia Emerald |
Erchonia Corporation |
Steven Shanks |
| K202306 |
11/25/2020 |
T3 Platform software |
Etiometry, Inc. |
Tim Hanson |
| K190942 |
01/07/2020 |
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color |
Ever Growth (Vietnam) Co. Ltd. |
Ming Lee |
| K202470 |
11/25/2020 |
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K202317 |
11/13/2020 |
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K192098 |
01/20/2020 |
EzMobile |
Ewoosoft Co., Ltd. |
Young Seok Kim |
| K192009 |
01/09/2020 |
LED Curing Light |
EZGO Group Inc. |
Hong Chen |
| K192161 |
01/22/2020 |
FastFit EMS System |
Fast Fit LLC |
Lisa Falcone |
| K191052 |
01/09/2020 |
HyaloGYN Vaginal Moisturizing Suppositories |
Fidia Farmaceutici S.p.A |
Giuseppina Lo Castro |
| K193547 |
01/17/2020 |
CustomizedBone Service |
Fin-Ceramica Faenza Spa |
Marina Monticelli |
| K192285 |
11/25/2020 |
CPR Face Shield |
Firstar Healthcare Company Limited (Guangzhou) |
Alice Zhao |
| K193045 |
01/18/2020 |
gekoÖ W-2 |
Firstkind Limited |
Neil Buckley |
| K201666 |
11/13/2020 |
SINGLE USE MANOMETER |
Flexicare Medical Limited |
Joel Biddle |
| K202172 |
11/19/2020 |
StarWalker |
Fotona d.o.o. |
Anja Pucer |
| K200931 |
11/24/2020 |
RF Surgical Generator |
Fulwell LLC |
Perla Melisa Mcliberty |
| K202959 |
11/24/2020 |
PolyLock Plating System |
Fusion Orthopedics, LLC |
Eli Jacobson |
| K193377 |
11/25/2020 |
TopLock Anchor System |
Fusion Orthopedics, LLC |
Kolby Black |
| K191432 |
01/24/2020 |
cortiQ PRO |
g.tec medical engineering GmbH |
Christoph Guger |
| K191125 |
01/15/2020 |
ADAS 3D |
Galgo Medical S.L |
Antoni Riu |
| K203032 |
11/02/2020 |
IcePearl 2.1 CX 90░ Needle, IcePearl 2.1 CX L 90░ Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90░ Needle, IceFORCE 2.1 CX L 90░ Needle, IceFORCE 2.1 CX Needle |
Galil Medical Inc. |
Amy McKinney |
| K200798 |
11/24/2020 |
G-CEM ONE |
GC America Inc. |
Mark Heiss |
| K192956 |
01/16/2020 |
Auto Positioning |
GE Hangwei Medical Systems, Co., Ltd. |
Yonghui Han |
| K202966 |
11/13/2020 |
SIGNA Architect |
GE Healthcare (GE Medical Systems, LLC) |
Andrew Menden |
| K191249 |
01/24/2020 |
CARESCAPE B450 |
GE Healthcare Finland Oy |
Joel Kent |
| K191149 |
01/21/2020 |
CARESCAPE B650 |
GE Healthcare Finland Oy |
Joel Kent |
| K191323 |
01/29/2020 |
Carescape B850 |
GE Healthcare Finland OY |
Joel Kent |
| K191322 |
01/22/2020 |
E-EEGX, N-EEGX |
GE Healthcare Finland Oy |
Joel Kent |
| K203169 |
11/20/2020 |
Revolution Ascend |
GE Healthcare Japan Corporation |
Tomohiro Ito |
| K201941 |
11/04/2020 |
Monitor B125, Monitor B105 |
GE Medical Systems Information Technologies, Inc. |
Joel Kent |
| K193289 |
11/12/2020 |
FastStroke, CT Perfusion 4D |
GE Medical Systems SCS |
Elizabeth Mathew |
| K193261 |
01/24/2020 |
FlightPlan for Embolization |
GE Medical Systems SCS |
Ning Wen |
| K193306 |
11/17/2020 |
PROView |
GE Medical Systems SCS |
Hong Cui |
| K192917 |
01/06/2020 |
ViewPoint 6 |
GE Medical Systems Ultrasound and |
Tracey Ortiz |
| K202132 |
11/13/2020 |
Venue |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K202233 |
11/18/2020 |
Venue Go |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K202035 |
11/20/2020 |
Vscan Air |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K190028 |
01/15/2020 |
UNO 30 |
Genadyne Biotechnologies |
Andrew Goh |
| K191489 |
01/08/2020 |
Genesys Spine 3DP Cervical Interbody System |
Genesys Spine |
Benjamin V. Keller |
| K200155 |
11/30/2020 |
Bright High Flow |
GENOSS Co., Ltd. |
Hong Jun Jeon |
| K193158 |
11/24/2020 |
ACENTÖ Central Venous Catheter |
Global Medikit Limited |
Mahendra Singh |
| K192115 |
01/14/2020 |
SABLE Expandable Spacer |
Globus Medical Inc. |
Kelly J. Baker |
| K201431 |
11/09/2020 |
OGYILI TENS/NMES Stimulator |
Gongguan Tutamen Metalwork Co., LTD |
Charles Shen |
| K190839 |
01/23/2020 |
GammaTile |
GT Medical Technologies |
Jessica Newhard |
| K202427 |
11/06/2020 |
Aqueduct 100 Plus Cervical Dilation Balloon Catheter |
GTIMD LLC |
Eran Levit |
| K202139 |
11/20/2020 |
Medical surgical mask |
Guangdong Kingfa SCI.&Tech.Co., Ltd. |
Yu Xiaoge |
| K201622 |
11/24/2020 |
Medical surgical mask |
Guangdong KINGFA Sci.&Tech.Co.,Ltd. |
Yu Xiaoge |
| K201294 |
11/27/2020 |
Pulse Oximeter |
Guangdong Long Yao Electronic Technology Co., Ltd. |
Lei Wang |
| K193339 |
01/30/2020 |
GTK Veress Needles |
Guangzhou T.K Medical Instrument Co., Ltd. |
Tracy Weng |
| K200402 |
11/25/2020 |
DR-HO'S Electro Therapy Conductive Gel |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K200018 |
01/31/2020 |
HAD1717MC |
H&abyz |
Nam Kyu Hur |
| K192503 |
11/19/2020 |
GM501 Wash with Phenol Red and Gentamicin |
Hamilton Thorne Incorporated |
Donald Fournier |
| K193504 |
01/23/2020 |
HardyDisk AST Cefiderocol 30ug (FDC30) |
Hardy Diagnostics |
Rianna Malherbe |
| K191940 |
11/03/2020 |
Palm NRG cellulite and muscle toning body device |
Heat In A Click |
Guy Levi |
| K202475 |
11/23/2020 |
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G |
Heraeus Medical GmbH |
Yannick Nils Hermanns |
| K202422 |
11/04/2020 |
Arietta 65 |
Hitachi Healthcare Americas |
Aaron Pierce |
| K201019 |
11/18/2020 |
Genius AI Detection |
Hologic, Inc. |
Deborah Thomas |
| K201683 |
11/03/2020 |
PMMA Block |
Huge Dental Material Co., Ltd. |
Maggie Zheng |
| K200693 |
11/19/2020 |
K2 MOBILE |
HULASER, Inc. |
InBae Park |
| K192859 |
01/24/2020 |
CareSens S Clear BT Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K193590 |
01/17/2020 |
CareSens S Fit BT Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K191821 |
01/23/2020 |
Blue Phantom PT |
IBA Dosimetry GmbH |
Andreas Suchi |
| K190316 |
01/14/2020 |
Icare ic200 |
Icare Finland Oy |
Hannes Hyvonen |
| K191229 |
01/21/2020 |
TrapIt |
IMDS Operations B.V. |
Edwin Schulting |
| K191692 |
01/10/2020 |
KardioScreen |
iMedrix Inc. (formerly Piitech Inc.) |
Srikanth Jadcherla |
| K191433 |
11/12/2020 |
AGILON« XO Shoulder Replacement System |
Implantcast GmbH |
Juliane Hoppner |
| K191380 |
01/29/2020 |
Quantum« Total Ankle Prosthesis |
In2Bones SAS |
Morgane Grenier |
| K192754 |
01/07/2020 |
Avenger Radial Head System |
In2Bones USA, LLC |
Christine Scifert |
| K193543 |
01/17/2020 |
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K200401 |
11/14/2020 |
Apogee |
Incoba Ltd. d/b/a Dynaris |
Lon Aylsworth |
| K193263 |
01/24/2020 |
Reprocessed Achieve Catheter Connecting Cable |
Innovative Health, LLC. |
Rick Ferreira |
| K202042 |
11/20/2020 |
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter |
Innovative Health, LLC. |
Rick Ferreira |
| K192893 |
01/03/2020 |
Straumann Ceramic Healing Abutments |
Institut Straumann AG |
Laure Kuhner Borsenberger |
| K193346 |
11/20/2020 |
Codman Surgical Patties & Strips |
Integra LifeSciences Corporation |
Alyssa Woodcock |
| K202198 |
11/03/2020 |
FlareHawk Interbody Fusion System |
Integrity Implants Inc. |
Lauren Kamer |
| K193192 |
01/31/2020 |
Tamper Evident Cap |
International Medical Industries Inc. |
David Meily |
| K181546 |
01/03/2020 |
Dillard Nasal Balloon Catheter |
Intuit Medical Products, LLC |
Jack Griffis |
| K202571 |
11/12/2020 |
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
Elaine Lee |
| K202370 |
11/16/2020 |
Ion Endoluminal System |
Intuitive Surgical, Inc. |
Jyoti Singh |
| K192216 |
01/02/2020 |
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP |
Invacare Corporation |
Elijah Wreh |
| K191093 |
01/22/2020 |
Isopure Dry Acid Dissolution System |
Isopure, Corp. |
Kevin Gillespie |
| K193193 |
11/16/2020 |
Telio CAD Abutment Solutions- extra systems |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K183284 |
01/15/2020 |
INTRAcel RF Microneedle System |
Jeisys Medical Inc. |
Sugun Lee |
| K183044 |
11/10/2020 |
JTK Dental Implant System |
Jiangyin Jintech Biotech Co., Ltd. |
Jie Zhang |
| K202515 |
11/24/2020 |
NUVO Implant System û NUVO Instrument Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K202851 |
11/27/2020 |
Spo2 Sensor |
JKH USA, LLC |
Bill Quanqin Dai |
| K192333 |
01/24/2020 |
Blue Nitrile Examination Gloves Powder Free |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Sburamaniam |
| K203154 |
11/05/2020 |
KASILOF Cervical Plate System |
Kahtnu Surgical, Inc |
Craig Wilcox |
| K201526 |
11/20/2020 |
TIPCAM1 Rubina Video Endoscope System |
Karl Storz Endoscopy America |
Mario Trujillo |
| K192523 |
01/24/2020 |
CMOS Video Esophagoscope SSU |
Karl Storz SE & Co. KG |
Alexey Davidov |
| K192090 |
01/27/2020 |
CMOS Video Rhino-Laryngoscope SSU |
Karl Storz SE & Co. KG |
Alexey Davidov |
| K201976 |
11/10/2020 |
SnapshotNIR |
Kent Imaging |
Liz Newell |
| K192612 |
11/13/2020 |
Kerecis Gingiva Graft |
Kerecis Limited |
Gudmundur Fertram Sigurjonsson |
| K202416 |
11/30/2020 |
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioi |
Kimberly Clark Corporation |
Juan Marquez |
| K201484 |
11/23/2020 |
Somnos Anti-Snoring Mouth Guard |
Koncept Innovators, LLC. |
Sylvan Newby |
| K193225 |
01/15/2020 |
KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography |
Konica Minolta Healthcare Americas, Inc |
Jan Maniscalco |
| K193060 |
01/30/2020 |
Noritake Super Porcelain EX-3 |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K190271 |
01/23/2020 |
FiteBac Cavity Cleanser |
Largent Health, LLC |
Kirk Kimmerling |
| K192966 |
01/10/2020 |
FlowMet |
Laser Associated Sciences, Inc. |
Sean White |
| K191501 |
01/03/2020 |
PALLAS 308/311 Solid-State UV Laser System |
Laseroptek Co., Ltd. |
Hong Chu |
| K191293 |
01/24/2020 |
LCCS VC-S RF Cannula |
LCCS Products Limited |
Nick XU |
| K193010 |
11/18/2020 |
Liebel-Flarsheim IBP Transfer Set |
Liebel-Flarsheim Company LLC |
Alice Lorenzo |
| K193258 |
01/31/2020 |
ProLift Expandable System |
Life Spine Inc. |
Angela Batker |
| K193284 |
01/31/2020 |
Physica LMC Knee System |
Limacorporate S.p.A |
Michela Zanotto |
| K200171 |
11/19/2020 |
SMR TT Augmented Glenoid System |
LimaCorporate S.p.A |
Michela Zanotto |
| K193007 |
01/17/2020 |
LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module |
LiNA Medical ApS |
Jaroslaw Mr≤wczynski |
| K190734 |
01/30/2020 |
Linshom Respiratory Monitoring Device (LRMD) |
Linshom Management LLC |
Ronen Feldman |
| K191210 |
01/09/2020 |
Longeviti ClearFit Cranial Implant |
Longeviti Neuro Solutions, LLC |
Jesse Christopher |
| K203081 |
11/24/2020 |
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture |
LSI Solutions |
Christopher B Miller |
| K203120 |
11/24/2020 |
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene |
LSI Solutions, Inc. |
Christopher B Miller |
| K193500 |
01/16/2020 |
Stellar M22 for Intense Pulsed Light (IPL) and Laser System |
Lumenis Ltd. |
Shlomit Segman |
| K200166 |
11/23/2020 |
Mirus Ligating Clip, Mirus Ligating Clip Applier |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| DEN200029 |
11/25/2020 |
Parallel |
Mahana Therapeutics, Inc. |
Jean-Noel Courvoisier |
| K191144 |
01/24/2020 |
Cellvizio 100 Series System with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K200912 |
11/18/2020 |
Freedom(R) - TiNbN Coated Knee |
Maxx Orthopedics, Inc. |
Priscilla Herpai |
| K193433 |
01/09/2020 |
AMIStem-C |
Medacta International SA |
Stefano Baj |
| K203149 |
11/16/2020 |
M.U.S.T. MINI Posterior Cervical Screws System |
Medacta International SA |
Stefano Baj |
| K193365 |
01/27/2020 |
M.U.S.T. Pedicle Screw System |
Medacta International SA |
Stefano Baj |
| K203076 |
11/06/2020 |
Mecta-C Stand Alone Extension |
Medacta International SA |
Stefano Baj |
| K191677 |
01/29/2020 |
MectaTap TI Suture Anchor |
Medacta International SA |
Stefano Baj |
| K200350 |
11/04/2020 |
MyHip Planner & Verifier |
Medacta International SA |
Stefano Baj |
| K192827 |
01/06/2020 |
Quadra-P |
Medacta International SA |
Stefano Baj |
| K202589 |
11/06/2020 |
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System |
Medartis AG |
Andrea Kiefer-Schweizer |
| K192984 |
01/24/2020 |
APTUS Clavicle System |
Medartis AG |
Andrea Kiefer-Schweizer |
| K191266 |
01/15/2020 |
VitalScan ANS |
Medeia, Inc. |
Slav Danev |
| K191123 |
01/06/2020 |
Multi-unit Abutments |
Medentika GmbH |
Gerhard Polzer |
| K193188 |
01/14/2020 |
MiiS Horus Eye Anterior Camera |
Medimaging Integrated Solution Inc. (MiiS) |
Yi-Ying Chen |
| K192563 |
01/17/2020 |
Altera gas Sampling Lines |
Meditera Tibbi Malzeme San. ve Tic. A.S. |
Cenk Kilic Kalkan |
| K192641 |
01/24/2020 |
Gemini Titan Sterilization Wrap |
Medline Industries, Inc. |
Jennifer Mason |
| K192985 |
01/21/2020 |
Medline Glide-On 3G Vinyl Examination Gloves |
Medline Industries, Inc. |
Stephanie Augsburg |
| K192315 |
01/10/2020 |
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Claire Pigman |
| K202449 |
11/18/2020 |
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50╡g/dm▓ per glove of Extractable Protein |
Medline Industries, Inc. |
Jennifer Mason |
| K192014 |
01/24/2020 |
SYPMHONYÖ OCT System |
Medos International SARL |
Sheree Geller |
| K202620 |
11/13/2020 |
FlexCath Advance Steerable Sheath and Dilator |
Medtronic CryoCath LP |
Matthew Lobeck |
| K202552 |
11/02/2020 |
Midas Rex Attachments and Dissecting Tools |
Medtronic Powered Surgical Solutions (MPSS) |
Jainam Shah |
| K192502 |
01/22/2020 |
Anatomic PEEKÖ Cervical Fusion System, Anatomic PEEKÖ PTC Cervical Fusion System, CapstoneÖ Spinal System, Capstone PTCÖ Spinal System, Capstone ControlÖ Spinal System, Capstone Control PTCÖ Spinal System, ClydesdaleÖ Spinal System, Clydesdale PTCÖ Spinal |
Medtronic Sofamor Danek USA, Inc |
Emmarie Halteman |
| K193011 |
01/10/2020 |
CD HorizonÖ Fenestrated Screw Set |
Medtronic Sofamor Danek USA, Inc. |
Lee Grant |
| K202800 |
11/18/2020 |
Pacific Plus PTA Catheter |
Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc) |
Rupali Gupta |
| K192406 |
11/25/2020 |
AveCure BT Microwave Ablation System |
MedWaves, Inc. |
Theodore Ormsby |
| K193507 |
01/17/2020 |
Merit ONE Snare System |
Merit Medical Systems, Inc. |
Mark Mullaney |
| K201269 |
11/09/2020 |
Accula Strep A Test |
Mesa Biotech, Inc. |
Barbara Stevens |
| K193548 |
01/18/2020 |
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K193576 |
11/20/2020 |
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Helen Chow |
| K200071 |
11/03/2020 |
Blue Beacon Submucosal Injectable Solution |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K192182 |
01/17/2020 |
C015 |
Micronica SRL |
Massimo Tomasi |
| K192684 |
01/22/2020 |
HydroPearl Microspheres |
MicroVention, Inc. |
Analia Staubly |
| K202269 |
11/25/2020 |
PRE-MILLED Abutment |
MIT Global Co., Ltd. |
Lim Rok Won |
| K200372 |
11/30/2020 |
Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil |
Modern Medical Equipment Manufacturing, Ltd. |
Jerry Cheung |
| K202090 |
11/22/2020 |
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underg |
Molnlycke Health Care, US LLC |
Leonard Stewart |
| K193375 |
01/03/2020 |
NeuroBlate System |
Monteris Medical |
David H. Mueller |
| K193239 |
01/03/2020 |
MPowRx Snoring Solution (also known as Good Morning Snore Solution) |
MPowRx Health and Wellness Products 2012 Inc |
Nancy Markley |
| K193102 |
01/06/2020 |
MRIaudio PREM System with MRIview |
MRIaudio, Inc. |
Joseph Caruso |
| K202274 |
11/09/2020 |
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscell |
Nalu Medical, Inc. |
Michele Chin-Purcell |
| K201669 |
11/06/2020 |
SimpleSENSE |
Nanowear Inc. |
Venkatesh Varadan |
| K201158 |
11/20/2020 |
NeuroStar Advanced Therapy |
Neuronetics, Inc. |
Gary Johnson |
| K191095 |
01/16/2020 |
Maxxi Snore Sensor |
Neurovirtual USA, INC. |
Eduardo Faria |
| K200081 |
11/13/2020 |
NEUWAVE Microwave Ablation System and Accessories |
NeuWave Medical, Inc. |
Dan Kosednar |
| K202962 |
11/20/2020 |
Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Ev |
New Deantronics Taiwan Ltd |
Jane Liu |
| K202307 |
11/17/2020 |
Activ Fuse |
Newclip Technics |
Gaelle Lussori |
| K191275 |
01/15/2020 |
AllÆInCath 035M PTA Balloon Dilatation Catheter |
NexStep Medical |
Angela Mallery |
| K190981 |
01/15/2020 |
NEX-D2 Posterior Fixation System |
Next OrthoSurgical |
Sartaj Kaur-Hurrle |
| K192349 |
01/23/2020 |
Bactisure Wound Lavage |
Next Science, LLC |
Jeanne Lee |
| K193370 |
01/21/2020 |
Nexxt Matrixx System |
Nexxt Spine LLC |
Andy Elsbury |
| K192687 |
01/09/2020 |
TrellOssÖ-L MPF |
Nexxt Spine LLC |
Andy Elsbury |
| K200873 |
11/20/2020 |
HALO |
NICo-Lab B.V. |
Merel Boers |
| DEN200033 |
11/06/2020 |
NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable |
NightWare, Inc |
Grady Hannah |
| K192307 |
01/10/2020 |
Nihon Kohden NKV-550 Series Ventilator System |
Nihon Kohden OrangeMed, Inc. |
Sheryl Higgins |
| K191802 |
01/16/2020 |
Electric Breast Pump |
Ningbo Huiyoo Baby Products Co. Ltd. |
Xiaoping Liu |
| K193155 |
11/25/2020 |
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis |
Nipro Renal Solutions USA, Corp. |
Vincent DeGrandchamp |
| K203156 |
11/20/2020 |
DTX Studio Clinic |
Nobel Biocare AB |
Wim Vrydag |
| K202344 |
11/16/2020 |
TiUltra Implants and Xeal Abutments |
Nobel Biocare AB |
Bernice Jim |
| K193246 |
01/24/2020 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Rachel Gilbert |
| K202244 |
11/05/2020 |
SPY-PHI System with SPY-PHI Fluorescence Assessment Software |
Novadaq Technologies ULC (now a part of Stryker) |
Agatha Szeliga |
| K202972 |
11/24/2020 |
Anterior Cervical Plate System |
Nutech Spine and Biologics |
Grant Horton |
| K183089 |
01/02/2020 |
Air Next |
NuvoAir AB |
Max Ladow |
| K200428 |
11/10/2020 |
Multi-Drive Interference Screw System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K193645 |
01/13/2020 |
nva, nvp, and nvt |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K203025 |
11/05/2020 |
LOBO Vascular Occlusion System (model LOBO-5) |
Okami Medical |
Jill Delsman |
| K203128 |
11/09/2020 |
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K193182 |
01/17/2020 |
Evis Exera III Duodenovideoscope Olympus TJF-Q190V |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K192761 |
01/17/2020 |
Asimov-MKS Imaging System |
OnLume Inc. |
Greg Bange |
| K202943 |
11/24/2020 |
OptoMonitor 3 |
Opsens Inc. |
Marc Chaunet |
| K191907 |
01/02/2020 |
OptoWire III |
Opsens Inc. |
Marc Chaunet |
| K201325 |
11/20/2020 |
Optomed Smartscope M5 with Optomed Smartscope FA |
Optomed Oyj |
Jyri LeskelΣ |
| K202764 |
11/20/2020 |
Ortho Solutions Plating System |
Ortho Solutions UK Ltd |
Andy Leither |
| K203138 |
11/18/2020 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
Jacki Koch |
| K192495 |
01/17/2020 |
Black Diamond Navigation Instruments |
Osseus Fusion Systems |
Robert Pace |
| K192941 |
01/30/2020 |
HySil Super Fast Impression Materials |
Osstem Implant Co., Ltd. |
Jungmin Yoo |
| K202883 |
11/25/2020 |
Sterile bone screw (PEEK ACL screw) |
Osteonic Co., Ltd. |
Sungmoo Hwang |
| K192995 |
01/10/2020 |
OsteoRemedies Hip Spacer System |
OsteoRemedies, LLC |
Eric Stookey |
| K202373 |
11/13/2020 |
APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
Haylie Hertz |
| K203011 |
11/13/2020 |
Monster Screw System |
Paragon 28, Inc. |
Haylie Hertz |
| K191227 |
01/24/2020 |
Paratrooper Plantar Plate Repair System |
Paragon 28, Inc. |
Eric Lintula |
| K192163 |
01/31/2020 |
TTC Phantom« Intramedullary Nail System |
Paragon 28, Inc. |
Haylie Hertz |
| K192750 |
01/16/2020 |
AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip |
Parcus Medical, LLC |
Paul Vagts |
| K193295 |
01/23/2020 |
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor |
Parcus Medical, LLC |
Paul Vagts |
| K191270 |
01/23/2020 |
Proneb Max |
PARI Respiratory Equipment, Inc. |
Michael Judge |
| K203024 |
11/24/2020 |
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge |
PENTAX of America, Inc. |
Gurvinder Singh Nanda |
| K202821 |
11/18/2020 |
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
Penumbra, Inc. |
Michaela Mahl |
| K200098 |
11/10/2020 |
VagiVital Aktivgel |
Peptonic Medical AB |
Dan Markusson |
| K193411 |
11/12/2020 |
O2asis Personal Oxygen Humidifier |
Perma Pure LLC |
Sidra Hankins |
| K193109 |
01/24/2020 |
MRCAT brain |
Philips Medical Systems MR Finland |
Janne Marvola |
| K203216 |
11/25/2020 |
The Multimodality Advanced Vessel Analysis |
Philips Medical Systems Nederland B.V. |
Vered Nitzan |
| K193454 |
01/24/2020 |
IQon Spectral CT |
Philips Medical Systems, Nederland B.V. |
Nimit Shah |
| K191195 |
01/03/2020 |
PiccGuard |
PiccGuard LLC |
Katie Justus |
| K192800 |
01/14/2020 |
Streamline TL Spinal Fixation System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Kurtis Hunsberger |
| K192585 |
01/29/2020 |
Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap |
PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC |
Ira Nusbaum |
| K192869 |
01/16/2020 |
SherpaPak Lung Preservation System , SherpaPak Liver Transport System |
Pragonix Technologies |
Lisa Anderson |
| K201827 |
11/05/2020 |
GR-17 Resin System |
Pro3dure Medical GmbH |
Martin Klare |
| K202682 |
11/24/2020 |
Promisemed Triple Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K202529 |
11/20/2020 |
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring |
ProSomnus Sleep Technologies, Inc. |
Divya Mavalli |
| K193499 |
11/04/2020 |
DigiGuide System |
ProtoMED, Inc. |
James Jimenez |
| K193440 |
01/09/2020 |
ER-REBOA PLUS Catheter |
Prytime Medical Devices, Inc |
Brian Young |
| K192860 |
11/19/2020 |
Sapphire Infusion Pump, Sapphire administration sets |
Q Core Medical Ltd. |
Guy Mlechkovich |
| K192535 |
01/31/2020 |
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia |
Qinhuangdao Audental Metal Technology Co., Ltd. |
Wang Xi |
| K193140 |
01/03/2020 |
Flex Body SPEEDER |
Quality Electrodynamics, LLC |
Eric Yeh |
| K202503 |
11/18/2020 |
Chrome |
Quanta System Spa |
Francesco Dell'Antonio |
| K201984 |
11/20/2020 |
MPS 3 ND Myocardial Protection System |
Quest Medical, Inc. |
Tosan Eweka |
| K193360 |
01/02/2020 |
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard |
Radmedix LLC |
Gabriel Issa |
| K191539 |
01/31/2020 |
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support |
Rapid Biomedical GmbH |
Christian Zimmermann |
| K200672 |
11/06/2020 |
Durex Penck Standard, Durex Penck XL |
RB Health (US) LLC |
Kyle Prince |
| K201840 |
11/04/2020 |
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) |
Rebound Therapeutics |
Naomi Gong |
| K200811 |
11/06/2020 |
cobas u 701 microscopy analyzer |
Roche Diagnostics |
Teresa Carrow |
| K192583 |
01/17/2020 |
PicoLazer Laser System |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K191717 |
01/13/2020 |
Route 92 Medical Sheath System |
Route 92 Medical Inc. |
Kathy Tansey |
| K203043 |
11/11/2020 |
Route 92 Medical 070 Access System |
Route 92 Medical, Inc. |
Kathy Tansey |
| K192767 |
01/08/2020 |
Clear Aligner |
Royal Dental Lab |
Mo Yuyun |
| K192926 |
01/17/2020 |
RxSight Insertion Device |
RxSight, Inc. |
Maureen O'Connell |
| K200992 |
11/17/2020 |
S.I.N. Dental Implant System |
S.I.N.-Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K202413 |
11/20/2020 |
LC ResinCal PC |
S&C Polymer Silicon- und Composite Spezialitaten GmbH |
Christian Bottcher |
| K202000 |
11/20/2020 |
Silatrix Oral Gel |
SA3, LLC |
Farbod Melamed |
| K201877 |
11/05/2020 |
OtoSet- Ear Cleaning System |
SafKan, Inc. |
Sahil Diwan |
| K190878 |
01/10/2020 |
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff |
Salter Labs, Inc. |
Mara Caler |
| K192903 |
01/06/2020 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
Ji Yea Lee |
| K201193 |
11/25/2020 |
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aòPOD-L NanoMetalene; SeaSpine Vu eòPOD System; and SeaSpine Reef TH System, SeaSpine Vu aòPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K192092 |
01/23/2020 |
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 |
Seca GmbH & Co. Kg |
Corinna Hatje |
| K202758 |
11/16/2020 |
Nd: YAG Laser Therapy Systems HM-YL900 |
Shangdong Huamei Technology Co., Ltd. |
Xu QingHua |
| K201601 |
11/10/2020 |
Medical Face Mask |
Shanghai Kindly Medical Instruments Co., Ltd. |
Xu Jianhai |
| K193241 |
01/26/2020 |
Emission Computed Tomography System |
Shanghai United Imaging Healthcare Co., Ltd |
Shumei Wang |
| K193480 |
01/31/2020 |
BIOEASY Multi-Drug Test Cup |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
Wenhau Yan |
| K201694 |
11/19/2020 |
Air Compression Therapy Device |
Shenzhen Dongjilian Electronics Co.,Ltd. |
Zhang Hong |
| K201991 |
11/23/2020 |
Medical surgical mask |
Shenzhen Everwin Precision Technology Co., Ltd. |
Guoshun Shi |
| K202980 |
11/19/2020 |
Laser Therapy Device |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
| K201990 |
11/09/2020 |
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., Ltd |
Jiang Haosen |
| K192547 |
01/17/2020 |
MAGLUMI 2000 HCG/▀-HCG |
Shenzhen New Industries Biomedical Engineering Co., Ltd |
Jie Rao |
| K192608 |
01/24/2020 |
Disposable SpO2 Sensor |
Shenzhen SINO-K Medical Technology Co., Ltd. |
Lao Chengxin |
| K203110 |
11/09/2020 |
iFuse Implant System - iFuse Navigation |
SI-BONE, Inc. |
Nancy Kaiser |
| K193493 |
01/15/2020 |
ADVIA Centaur Total IgE (tIgE) |
Siemens Healthcare Diagnostics Inc. |
Ian Thompson |
| K192462 |
01/31/2020 |
syngo.MR Applications |
Siemens Medical Solutions USA Inc. |
Cordell L. Fields |
| K193257 |
01/31/2020 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K193562 |
11/06/2020 |
AI-Rad Companion Organs RT |
Siemens Medical Solutions USA, Inc. |
Lauren Bentley |
| K201195 |
11/18/2020 |
syngo.via MI Workflows, syngo MBF |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K200706 |
11/16/2020 |
Sientra OPUS Silicone Gel Breast Implant Sizer |
Sientra, Inc |
JoAnn Kuhne |
| K202762 |
11/16/2020 |
Circular Fixation with Balanced Cable Transport |
Smith & Nephew, Inc. |
Crystal Higgenbottom-Shaffer |
| K201918 |
11/16/2020 |
EVOS Large Fragment Plating System |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K191678 |
01/10/2020 |
IP Converter |
Sony Electronics Inc. |
Shogo Obuchi |
| K200612 |
11/17/2020 |
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line |
Sorin Group Italia S.r.l. |
Luigi Vecchi |
| K202664 |
11/06/2020 |
Clio Prime and Clio Pedo |
Sota Precision Optics, Inc. dba SOTA Imaging |
Bumsuk Kim |
| K192211 |
01/17/2020 |
SoundBite Console, SoundBite Active Wire 18 |
SoundBite Medical Solution Inc. |
Marc Andre Cote |
| K192606 |
01/17/2020 |
SAC2 - Electrode Cream |
Spes Medica S.r.l. |
Giogio Facco |
| K193465 |
01/10/2020 |
CorticaLINK Spinal Fusion Platform |
Spine Smith Holdings, LLC |
Nickolas G. Kriska |
| K202476 |
11/05/2020 |
Salvo« Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K192993 |
01/22/2020 |
SCARLET AL-T |
Spineart |
Franck Pennesi |
| K203061 |
11/06/2020 |
Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco |
STERIS Corporation |
Anthony Piotrkowski |
| K202583 |
11/06/2020 |
BioShield biopsy valve EUS - Linear |
Steris Corporation |
Jacqueline Oliver |
| K191715 |
01/27/2020 |
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile |
STERIS Corporation |
Jennifer Nalepka |
| K193478 |
01/14/2020 |
XTRAC Momentum Excimer Laser System |
Strata Skin Sciences, Inc. |
Chuck Mierkiewicz |
| K202355 |
11/13/2020 |
Stryker Omega PEEK Knotless Anchor System |
Stryker |
Katie Farraro |
| K182084 |
11/04/2020 |
Sweden & Martina Surgical Tray (Model ZSHORTY-INT) |
Sweden & Martina S.p.A. |
Alessia Pezzato |
| K192429 |
01/14/2020 |
Dental Pain Eraser |
Synapse Dental |
Cosmo Haralambidis |
| K193570 |
01/17/2020 |
Dental Pain Eraser |
Synapse Dental |
Cosmo Haralambidis |
| K201741 |
11/05/2020 |
Gabriel 3 Way EnFit Valve |
Syncro Medical Innovations, Inc. |
Sabry Gabriel |
| K192177 |
11/25/2020 |
SysMed S/T |
SysMed (China) Co., Ltd |
Yue Jian |
| K202178 |
11/13/2020 |
VersaLoop Anchor System |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K200750 |
11/06/2020 |
Neuro.Al Algorithm |
TeraRecon, Inc. |
Megha Jain |
| K193510 |
01/28/2020 |
Terason uSmart3200T Ultrasound System |
Teratech Corporation |
Steven R. Broadstone |
| K193125 |
01/06/2020 |
R2P Destination Slender Guiding Sheath |
Terumo Medical Corporation |
Liang Lu |
| K193512 |
01/26/2020 |
THD Procto Software System |
THD SpA |
Filippo Bastia |
| K193024 |
01/08/2020 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K203040 |
11/13/2020 |
TSolution One Total Knee Application |
THINK Surgical, Inc. |
Meliha Mulalic |
| K191581 |
01/08/2020 |
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device |
Titan Spine, Inc |
Kelly McDonnell |
| K193385 |
11/12/2020 |
TP Orthodontics Clear Aligner System |
TP Orthodontics Inc. |
Stephanie Thyen |
| K192696 |
01/05/2020 |
TriMed ASET Foot Plating System |
TriMed, Inc. |
David Medoff |
| K192621 |
11/06/2020 |
Medical RF |
Triworks Group SRL |
Elio Piero Berchicci |
| K183106 |
01/29/2020 |
TruAbutment DS |
TruAbutment Inc. |
Kiyoon Nam |
| K193222 |
01/20/2020 |
Tyber Medical Anatomical Plating System |
Tyber Medical LLC |
Mark Schenk |
| K192974 |
01/08/2020 |
Tyber Medical Trauma Screw |
Tyber Medical LLC |
Mark Schenk |
| K192975 |
01/09/2020 |
Tyber Medical Trauma Screws |
Tyber Medical LLC |
Mark Schenk |
| K191056 |
01/03/2020 |
Conformity stem, cemented |
United Orthopedic Corporation |
Lois Ho |
| K191061 |
01/02/2020 |
Optilume Basic Urological Balloon Dilation Catheter |
Urotronic Inc |
David Perry |
| K191472 |
01/29/2020 |
Biopsy Needle |
Ushare Medical Inc. |
Yan Wang |
| K191109 |
01/22/2020 |
Spectra Q |
Uzinmedicare Co. |
Jisun Lee |
| K192454 |
01/15/2020 |
Wattson Temporary Pacing Guidewire |
Vascular Solutions |
Nancy Frame |
| K193569 |
01/21/2020 |
PIVO(TM) |
Velano Vascular |
Tiffini Wittwer |
| K193488 |
01/16/2020 |
GlideScope BFlex 3.8 Single-Use Bronchoscope |
Verathon Medical (Canada) ULC |
Teresa Davidson |
| K192415 |
01/17/2020 |
Study Watch with Irregular Pulse Monitor |
Verily Life Sciences LLC |
Connie Pascual |
| K203082 |
11/12/2020 |
Insight Infrared Video Goggles |
Vestibular First |
Helena Esmonde |
| K190120 |
01/23/2020 |
VINNO 8, VINNO 6, VINNO 5 |
VINNO Technology (Suzhou) Co., Ltd. |
Wei Wang |
| K202490 |
11/16/2020 |
Avid CT2 |
Vision Quest Industries Inc./dba VQ OrthoCare |
Mohamed Ouerghi |
| K193431 |
01/03/2020 |
AlignRT Plus |
Vision RT Ltd |
Arun Mahendran |
| K191926 |
01/29/2020 |
VITA VIONIC Bond |
VITA Zanhnfabrik H. Rauter GmbH Co. |
Bernd Walker |
| K191837 |
01/29/2020 |
UniSmile Clear Aligner System |
Vitang Technology, LLC |
Xiangxu Chen |
| K192146 |
01/28/2020 |
V-DENUPET |
Vitromed GmbH |
Deepesh Changat |
| K193285 |
11/20/2020 |
V-ONESTEP |
Vitromed GmbH |
Deepesh Changat |
| K191870 |
01/07/2020 |
VV330 Continuous ECG Platform, VivaLNK Adhesive Patch |
VivaLNK, Inc. |
Quoi V. Huynh |
| K193611 |
01/16/2020 |
Viveve 2.0 System |
Viveve Medical, Inc. |
Kevin Robison |
| K200472 |
11/18/2020 |
Viveve System |
Viveve Medical, Inc. |
Kevin Robison |
| K201091 |
11/06/2020 |
V-Print splint |
VOCO GmbH |
M. Th. Plaumann |
| K201998 |
11/17/2020 |
JETi AIO Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K193191 |
11/20/2020 |
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag |
Weinmann Emergency Medical Technology GmbH + Co. KG |
Kristin Ratschiller |
| K192339 |
01/30/2020 |
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord |
Wilson-Cook Medical, Inc. |
Marge Walls-Walker |
| K192635 |
01/17/2020 |
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) |
WRP ASIA PACIFIC SDN BHD |
Hasnah Abdul Hamid |
| K202931 |
11/17/2020 |
Disposable Trocar |
Wuxi Shukang Medical Appliance Co., Ltd. |
Xiaoqing Yuan |
| K193315 |
01/27/2020 |
Xenocor Articulating Xenoscope Laparoscope |
Xenocor, Inc |
Evan Kelso |
| K201825 |
11/20/2020 |
MiniCAT 2D |
Xoran Technologies LLC |
Mark McGarrow |
| K190243 |
01/03/2020 |
Z5-BL |
Z-Systems AG |
Rubino DiGirolamo |
| K202624 |
11/04/2020 |
Z-Span Plate System |
Zavation Medical Products LLC |
Frankie Cummins |
| K193566 |
01/21/2020 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc. |
Tammy Wharton |
| K201523 |
11/12/2020 |
Sharps container |
Zhejiang Gongdong Medical Technology Co., Ltd |
Weifeng Zhong |
| K202250 |
11/25/2020 |
Dermatological Carbon Dioxide Laser Systems |
Zhuolu Jontelaser Manufacturing Technology Co., Ltd |
Karen Liu |
| K193099 |
01/29/2020 |
Anatomical Shoulder System |
Zimmer GmbH |
Roberto Tommasini |
| K193223 |
01/24/2020 |
Persona Personalized Knee System |
Zimmer, Inc |
Gregory Foster |
