| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K200496 |
02/28/2020 |
Aer X |
3B Medical Inc. |
Yasser Estafanous |
| K200306 |
02/06/2020 |
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit |
Abbott (formerly Thoratec Corporation) |
Bindya Gadhia |
| K200492 |
02/28/2020 |
i-STAT CG4+ Cartridge with the i-STAT 1 System |
Abbott point of Care, Inc. |
Susan Tibedo |
| K200387 |
02/18/2020 |
Ace Medical Surgical Instruments |
Ace Medical |
Alex Ebner |
| K200300 |
02/06/2020 |
VivAer Stylus |
Aerin Medical Inc |
Matthew M Hull |
| K200361 |
02/14/2020 |
Akros Scruture Anchor LisFranc Repair Kit |
Akros Medical |
Charles Horrell |
| K200311 |
02/06/2020 |
VersaWrap Tendon Protector |
Alafair Biosciences Inc |
Ben Walthall |
| K200450 |
02/24/2020 |
X-Cube 70 |
Alpinion Medical Systems Co., Ltd. |
Boyeon CHO |
| K200449 |
02/24/2020 |
X-Cube 90 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K200322 |
02/10/2020 |
Altus Spine Pedicle Screw System |
Altus Partners, LLC |
Mark Melton |
| K200268 |
02/03/2020 |
HaloÖ Single-Loop Snare Kit |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K200413 |
02/19/2020 |
Symphony |
Aroa Biosurgery Ltd. |
Tina O'Brien |
| K200341 |
02/11/2020 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Jessica L. Singelais |
| K200433 |
02/21/2020 |
iBalance UKA Tibial Tray Implant |
Arthrex Inc. |
Ivette Galmez |
| K200352 |
02/13/2020 |
Axis Spine Technologies ALIF |
Axis Spine Technologies Ltd |
Edwin Lindsay |
| K200266 |
02/03/2020 |
BD Centro Vena Acute Central Line (7 French Dual Lumen) |
Bard Access Systems, Inc. (Bard has joined BD) |
Breanna Casados |
| K200280 |
02/04/2020 |
MEDRAD Imaging Bulk Package Transfer Spike |
Bayer Medical Care Inc. |
Leslie S O'Nan |
| K200462 |
02/25/2020 |
EtchPro Etching Gel |
Belport Company, Inc., Gingi-Pak |
Daniel Wang |
| K200262 |
02/03/2020 |
L100 Go System |
Bioness Inc. |
Mercedes Bayani |
| K200482 |
02/27/2020 |
StimRouter Neuromodulation System |
Bioness Inc. |
Sageev George |
| K200359 |
02/13/2020 |
NuEra Tight, NuEra Tight EMS |
Bios s.r.l. |
Maurizio Bianchi |
| K200444 |
02/24/2020 |
Biomonitor III, Biomonitor IIIm |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K200483 |
02/27/2020 |
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller |
Boston Scientific Corporation |
Inderdeep Tiwana |
| K200257 |
02/03/2020 |
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System |
Boston Scientific Corporation |
Catherine Sanford |
| K200435 |
02/24/2020 |
Catalyst+, Catalyst+ HD |
C-Rad Positioning AB |
Thomas Matzen |
| K200274 |
02/04/2020 |
CariCloud |
Caristo Diagnostics |
James Davis |
| K200313 |
02/06/2020 |
VIVO |
Catheter Precision, Inc. |
Steve Adler |
| K200457 |
02/25/2020 |
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming |
CC Wellness LLC |
Marlent Perez |
| K200370 |
02/14/2020 |
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit |
Centers For Disease Control And Prevention |
Yon Yu |
| K200445 |
02/24/2020 |
The C100 Contactless Breathing Monitor |
Circadia Technologies Ltd. |
Michal Maslik |
| K200395 |
02/18/2020 |
LOSPA II Knee System (EXULT Knee Replacement System) |
Corentec Co., Ltd |
Sungwon Yang |
| K200267 |
02/03/2020 |
LOSPA« ISÖ Spinal Fixation System |
Corentec Co., Ltd. |
Sungwon Yang |
| K200427 |
02/21/2020 |
Sonicision Cordless Ultrasonic Dissector |
Covidien, llc |
Celso Duran |
| K200373 |
02/14/2020 |
Deltaven Fast Flash Closed I.V. Catheter Systems |
Delta Med Spa |
Raschi Olga |
| K200319 |
02/07/2020 |
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K200258 |
02/03/2020 |
Edwards eSheath Introducer Set |
Edwards Lifesciences |
Vilma Arechiga |
| K200358 |
02/13/2020 |
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula |
Edwards Lifesciences LLC |
Anna Califato |
| K200499 |
02/28/2020 |
QuickDraw Venous Cannula |
Edwards Lifesciences LLC |
Diem My Nguyen |
| K200485 |
02/27/2020 |
RadiForce RX1270, RadiForce RX1270-AR |
EIZO Corporation |
Hiroaki Hashimoto |
| K200355 |
02/13/2020 |
Duranext Abutments |
Elegant Dental Corp. |
Gary Fingerman |
| K200253 |
02/03/2020 |
Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector |
Ethicon Endo-Surgery |
Emily Nesbitt |
| K200420 |
02/20/2020 |
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K200337 |
02/11/2020 |
FloPatch (FP120) |
Flosonics Medical (r/a 1929803 Ontario Corp.) |
Andrew Eibl |
| K200481 |
02/27/2020 |
Andorate Biopsy Valve, Andorate Biopsy Irrigator |
GA Health Company Limited |
Cindy Ye |
| K200495 |
02/28/2020 |
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve |
GA Health Company Limited |
Cindy Ye |
| K200479 |
02/27/2020 |
AquaPulse Auxiliary Water Connector |
GA Health Company Limited |
Cindy Ye |
| K200388 |
02/18/2020 |
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector |
GA Health Company Limited |
Cindy Ye |
| K200494 |
02/28/2020 |
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES |
GE Healthcare |
Joel Kent |
| K200497 |
02/28/2020 |
Vivid S60N, Vivid S70N |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K200469 |
02/26/2020 |
PAPAYA 3D Premium & PAPAYA 3D Premium Plus |
Genoray Co.,Ltd |
Hyunju Hwang |
| K200343 |
02/11/2020 |
FusionFrame Ring Lock System |
GLW Medical Innovation |
Elijah Wreh |
| K200305 |
02/06/2020 |
NPseal |
Guard Medical Inc. |
Machiel Van der Leest |
| K200263 |
02/03/2020 |
Health Line CT Midline Catheter |
Health Line International Corporation |
Aaron G Faulkner |
| K200498 |
02/28/2020 |
SCENARIA View |
Hitachi Healthcare Americas |
Aaron Pierce |
| K200436 |
02/24/2020 |
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit |
Hologic, Inc. |
Jill Wyland |
| K200406 |
02/19/2020 |
Evolve Breast Pump |
Hygeia II Medical Group, Inc. |
Brett Nakfoor |
| K200295 |
02/05/2020 |
IlluminOss Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K200396 |
02/18/2020 |
Insight Enhanced DRF Digital Imaging System |
Imaging Engineering, LLC |
George Jachode |
| K200324 |
02/10/2020 |
NHancer Rx |
IMDS Operations B.V. |
E Schulting |
| K200265 |
02/03/2020 |
Surgical Drills |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K200424 |
02/20/2020 |
Giotto Class (Models - 3000X-YY and 4000X-YY) |
IMS GIOTTO S.p.A. |
Antonella Rossi |
| K200293 |
02/05/2020 |
InMode System with vTone Applicator |
InMode Ltd. |
Amit Goren |
| K200385 |
02/18/2020 |
CONTINUUM PACS |
Integrated Ophthalmic Systems, Inc. |
Matthew Carnevale |
| K200419 |
02/20/2020 |
Kalera Vacuum Aspiration Catheter (K-VAC) |
Kalera Medical, Inc. |
Jee Shin |
| K200390 |
02/18/2020 |
V.A.C. DERMATAC Drape |
KCI USA, Inc |
Margaret Marsh |
| K200328 |
02/10/2020 |
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System |
Kyocera Medical Technologies, Inc. |
Anthony DeBenedictis |
| K200287 |
02/05/2020 |
BP-BT Kiosk |
LD Technology LLC |
Albert Maarek |
| K200464 |
02/26/2020 |
LG Pra. L Derma LD Scalp Care |
LG Electronics, Inc. |
Eunmi Ji |
| K200338 |
02/11/2020 |
ProLift Lateral Fixated |
Life Spine Inc. |
Angela Batker |
| K200308 |
02/06/2020 |
MTS Lefamulin 0.016- 256 ?g/mL |
Liofilchem s. r. 1. |
Fabio Brocco |
| K200277 |
02/04/2020 |
Livongo Blood Glucose Monitoring System (BG1000) |
Livongo Health, Inc. |
Jacob Gendler |
| K200501 |
02/28/2020 |
ArtiSential Laparoscopic Instrument-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K200389 |
02/18/2020 |
INOmax DSIR Plus |
Mallinckrodt Manufacturing LLC |
David Trueblood |
| K200353 |
02/13/2020 |
ManaFlow |
ManaMed, Inc |
Trevor Theriot |
| K200351 |
02/12/2020 |
PlasmaFlight |
ManaMed, Inc. |
Trevor Theriot |
| K200356 |
02/13/2020 |
MEDO ARIA |
Medo.ai |
Dornoosh Zonoobi |
| K200456 |
02/25/2020 |
Becker External Drainage and Monitoring System |
Medtronic, Inc. |
Nancy Hampton |
| K200283 |
02/04/2020 |
Medussa-PL Cage |
Medyssey USA, Inc. |
Shawn Kim |
| K200250 |
02/03/2020 |
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor |
Megadyne Medical Products, Inc. |
Sharon Sussex |
| K200297 |
02/06/2020 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K200500 |
02/28/2020 |
Molekule Air Pro RX |
Molekule, Inc. |
Frank Bianco |
| K200443 |
02/24/2020 |
EndoTool IV 1.10 |
Monarch Medical Technologies, LLC |
Ann Marie Gaitan |
| K200348 |
02/12/2020 |
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) |
Neocis Inc. |
Thomas E. Claiborne |
| K200441 |
02/24/2020 |
UroLift Advanced Tissue Control (ATC) System |
NeoTract, Inc. |
Brian Gall |
| K200455 |
02/25/2020 |
Trigger Switch and Cord |
New Deantronics Taiwan, Ltd. |
Jane Liu |
| K200471 |
02/26/2020 |
Infrared Thermometer Model Number RN-60A,RN-60B |
Ningbo Ranor Medical Science & Technology Co., Ltd. |
Emma Hu |
| K200349 |
02/12/2020 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Rachel Gilbert |
| K200403 |
02/19/2020 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Rachel Gilbert |
| K200430 |
02/21/2020 |
Precice« Ankle Salvage System |
NuVasive Specialized Orthopedics, Inc. |
Ivanna Lopez |
| K200397 |
02/18/2020 |
Single Use Biopsy Forceps FB-456D |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K200369 |
02/14/2020 |
OES Elite Ureteroscopes and Accessories |
Olympus Winter & Ibe GmbH |
Stefanie Weber |
| K200275 |
02/04/2020 |
OVision Imaging System |
Ophthalmic Labs, Inc. |
Matthew Carnevale |
| K200254 |
02/03/2020 |
Mydriatic Hyperspectral Retinal Camera (MHRC-C1) |
Optina Diagnostics |
Jean-Philippe Sylvestre |
| K200325 |
02/10/2020 |
Orbit Subretinal Delivery System |
Orbit Biomedical |
Stacey Backlund |
| K200269 |
02/04/2020 |
Sapphire II PRO |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K200282 |
02/04/2020 |
Orfit Aerial Couchtop |
Orfit Industries NV |
Eddy Marivoet |
| K200281 |
02/04/2020 |
The Gecko Spinal System |
Ortho Development Corporation |
Divya Palan |
| K200259 |
02/03/2020 |
Headless Compression Screw System |
OsteoCentric Extremities, LLC |
Todd Evans |
| K200330 |
02/10/2020 |
RC-Prime Root Canal Preparation Cream |
Pac-Dent, Inc |
Daniel Wang |
| K200409 |
02/19/2020 |
Pelvital System |
Pelvital USA, Inc. |
Dale Wahlstrom |
| K200279 |
02/04/2020 |
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine |
Phadia AB |
Carina Magnusson |
| K200410 |
02/19/2020 |
Reconnaissance PV .018 OTW Digital IVUS Catheter |
Philips Image Guided Therapy Corporation |
Mary Stanners |
| K200304 |
02/06/2020 |
EPIQ Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Linda Schulz |
| K200278 |
02/04/2020 |
CytoCore |
Praxis Medical, LLC |
John Fisher |
| K200303 |
02/06/2020 |
Reform Pedicle Screw System |
Precision Spine |
Micheal C. Dawson |
| K200459 |
02/25/2020 |
pREBOA-PRO Catheter |
Prytime Medical Devices, Inc. |
Brian Young |
| K200477 |
02/27/2020 |
Flex Body Speeder |
Quality Electrodynamics, LLC |
Eric Yeh |
| K200438 |
02/24/2020 |
MPS 3 Myocardial Protection System |
Quest Medical, Inc. |
Tosan Onosode |
| K200363 |
02/14/2020 |
Quidel Triage« TOX Drug Screen, 94600 |
Quidel Cardiovascular Inc. |
Rachael S Williamson |
| K200317 |
02/07/2020 |
Support Catheter |
QXMedical, LLC |
Fernando Di Caprio |
| K200487 |
02/27/2020 |
RayCare 3.1 |
RaySearch Laboratories AB (publ) |
Viktoria Hammarstedt |
| K200284 |
02/05/2020 |
R-Sensor, R-Sensor |
Remedi Co. Ltd. |
Jadon Koo |
| K200480 |
02/27/2020 |
DreamStation 2 System, DreamStation 2 Advanced System |
Respironics, Inc. |
Andy Zaltwanger |
| K200417 |
02/20/2020 |
RIST Radial Access Catheter |
RIST Neurovascular, Inc. |
Marianne Grumwaldt |
| K200326 |
02/10/2020 |
Powder Free Nitrile Examination Glove (Aqua Green) |
Riverstone Resources SDN BHD |
Suresh Kumar |
| K200339 |
02/11/2020 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
Scully Kim |
| K200381 |
02/18/2020 |
Daytona« Small Stature Spinal System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K200290 |
02/05/2020 |
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) |
SeaSpine Orthopedics Corporation |
Caryn Sailor |
| K200354 |
02/13/2020 |
Electronic stimulator |
Shenzhen Dongjilian Electronics Co.,Ltd. |
Zhang Hong |
| K200437 |
02/24/2020 |
Blood Pressure Monitor |
Shenzhen Jamr Technology Co., Ltd. |
Luo Fusheng |
| K200251 |
02/03/2020 |
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
Shi Jufang |
| K200411 |
02/19/2020 |
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
Shi Jufang |
| K200474 |
02/26/2020 |
Symbia 6.7 |
Siemens Medical Solutions USA, Inc. |
Cynthia Busch |
| K200367 |
02/14/2020 |
Distal Humerus Plating System |
Skeletal Dynamics, Inc. |
Ana M. Escagedo |
| K200392 |
02/18/2020 |
REXSIN |
SM ENG CO., LTD |
Soon-Gu Lee |
| K200407 |
02/19/2020 |
LEGION Inserts with JRNY Lock |
Smith & Nephew, Inc. |
Konrad Wolfmeyer |
| K200331 |
02/10/2020 |
Rapid Acoustic Pulse Device |
Soliton Inc. |
Leslie Honda |
| K200312 |
02/06/2020 |
Tryptik Ti |
Spineart |
Frank Pennesi |
| DEN200010 |
02/19/2020 |
Spineology Interbody Fusion System |
Spineology, Inc. |
Andrew Adams |
| K200446 |
02/24/2020 |
STERIS Patient Warming System |
STERIS Corporation |
Gregory Land |
| K200252 |
02/03/2020 |
Getinge Assured MI Steam Migrating Integrator |
SteriTec Products MFG Co Inc |
Jonathan Rutigliano |
| K200310 |
02/06/2020 |
1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality |
Stryker |
April Malmborg |
| K200493 |
02/28/2020 |
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover |
Stryker Corporation |
Corinne Larke-Grass |
| K200398 |
02/18/2020 |
AxSOS 3 AF System and AxSOS 3 Ti System |
Stryker GmbH |
Paul Nelson |
| K200431 |
02/21/2020 |
3D GraftRasp System |
SurGenTec |
Andrew Shoup |
| K200327 |
02/10/2020 |
Evry |
Synaptive Medical Inc. |
Maham Ansari |
| K200467 |
02/26/2020 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K200400 |
02/18/2020 |
Systane iLux2 |
Tear Film Innovations, Inc. |
Neal Hartman |
| K200272 |
02/04/2020 |
Terragene Chemdye |
Terragene SA |
Maria Victoria Rocha |
| K200379 |
02/18/2020 |
Super Sheath |
TOGO MEDIKIT CO., LTD. |
Daisuke Nagamizu |
| K200360 |
02/13/2020 |
TrackX |
Track X Technology, LLC |
David Skwerer |
| K200314 |
02/06/2020 |
Capere Thrombectomy System |
Vascular Medcure, Inc. |
Jeffrey P DuMontelle |
| K200285 |
02/05/2020 |
VenaOne |
Vena Group, LLC |
Kasey Vukson |
| K200418 |
02/20/2020 |
VIVIX-S VW |
Vieworks Co., Ltd. |
Jordin Kim |
| K200468 |
02/26/2020 |
V30 system, V20 system, V10 system, V-FC Handpiece |
Viora Ltd. |
Simona Forman Krant |
| K200294 |
02/05/2020 |
GrandioSO Light Flow |
VOCO GmbH |
M Th Plaumann |
| K200383 |
02/18/2020 |
Wiggins Medical Surgical Instruments |
Wiggins Medical |
Alex Ebner |
| K200453 |
02/24/2020 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC |
YTY Industry (Manjung) Sdn Bhd |
Punitha Samy |
| K200315 |
02/07/2020 |
Ziostation2 |
Ziosoft, Inc. |
Tsuyoshi Nagata |
