| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K200214 |
02/24/2020 |
3D Predict |
3D Smile USA, Inc |
Marina Domracheva |
| K192192 |
02/26/2020 |
VSP System |
3D Systems |
Kim Torluemke |
| K193154 |
02/07/2020 |
3M Attest Super Rapid 5 Steam-Plus Challenge Pack |
3M Company |
Mary Fretland |
| K192305 |
02/27/2020 |
Colibri Endoscopy System |
3NT Medical Ltd. |
Ehud Bendory |
| K183680 |
02/28/2020 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Susan Tibedo |
| K191298 |
02/07/2020 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Susan Tibedo |
| K183678 |
02/07/2020 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott point of Care, Inc. |
Susan Tibedo |
| K183688 |
02/07/2020 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care, Inc. |
Susan Tibedo |
| K191360 |
02/14/2020 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care, Inc. |
Susan Tibedo |
| K191514 |
02/18/2020 |
CareStart Flu A&B Plus |
Access Bio, Inc. |
Sang Joon Han |
| K193015 |
02/20/2020 |
HydroPICC (PICC-142) |
Access Vascular, Inc |
Brian Hanley |
| K193013 |
02/11/2020 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Karla Schaffner |
| K192898 |
02/25/2020 |
PneumoLiner |
Advanced Surgical Concepts |
Edward Hyland |
| K200050 |
02/04/2020 |
Akesis Galaxy RTx |
Akesis Inc |
Christopher Brown |
| K191290 |
02/06/2020 |
Ancora Nerve Block Catheter Set |
Ancora Medical Technology |
Chunyuan Qiu |
| K193268 |
02/27/2020 |
APrioCore Plus |
AprioMed AB |
Katrin Svensson |
| K192846 |
02/10/2020 |
Argen Clear Aligner, Argen Clear Aligner Premium |
Argen Corporation |
Paul Cascone |
| K190192 |
02/10/2020 |
K3Pro Konus New Abutments and Implants |
Argon Med. Productions Vertriebs Gesellschaft MBH Co Kg |
Richard Donaca |
| K200197 |
02/26/2020 |
ARK Fentanyl II Assay |
ARK Diagnostics, Inc. |
Thomas Houts |
| K193156 |
02/10/2020 |
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws |
Arthrex Inc. |
Rebecca R. Homan |
| K192372 |
02/14/2020 |
ASCEND Image Viewer |
Ascend Hit |
Andy Miller |
| K190806 |
02/20/2020 |
Flowart |
ASSET MEDIKAL TASARIM A.S. |
Ebru Sirali |
| DEN190023 |
02/21/2020 |
AmplideX Fragile X Dx & Carrier Screen Kit |
Asuragen, Inc. |
Bernard Andruss |
| K192570 |
02/28/2020 |
Atlas Spine Expandable Cervical Standalone Interbody System |
Atlas Spine, Inc. |
Thomas Smith |
| K183148 |
02/04/2020 |
OKLand Patient Return Electrode Pad |
Auckland Medical Polymer(Tianjin) Co., Ltd. |
Bei Lei Gao |
| K192491 |
02/21/2020 |
Coolief Radiofrequency Generator (CRG) System |
Avanos Medical, Inc. |
Thomas Kozma |
| K192617 |
02/20/2020 |
Gemini 810+980 Soft Tissue Laser |
Azena Medical, LLC |
Lindsay Tilton |
| K200030 |
02/01/2020 |
Optima Coil System |
Balt USA, LLC |
Michael Peters |
| DEN190040 |
02/07/2020 |
Caption Guidance |
Bay Labs, Inc. |
Sam Surette |
| K191556 |
02/28/2020 |
Red Dot |
Behold.AI Technologies Limited |
Simon Rasalingham |
| K191411 |
02/06/2020 |
Ah!Yes Ob Coco Personal Lubricant |
Bio-Tech Lubricants Ltd |
Sarah Brooks |
| K193168 |
02/13/2020 |
Agilon Moldable |
Biogennix, LLC. |
Timothy Bumbalough |
| K190259 |
02/07/2020 |
Vesta RF Cannula |
Biomerics |
Jake Wakley |
| K193567 |
02/14/2020 |
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 û >=16 ug/mL) |
BioMerieux, Inc. |
Esther Hernandez |
| K193451 |
02/24/2020 |
Titanium Interference Screws |
Biomet Inc. |
Saveetha Raghupathi |
| K193533 |
02/20/2020 |
WIN Flexible Nail System |
Biomet Inc. |
Dominique Dompor |
| K192683 |
02/27/2020 |
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads |
Biomet UK Ltd. |
Lisa Ingram |
| K190641 |
02/21/2020 |
AR_N SLA Type Implant System |
Biotem Co., Ltd. |
Hong Koo Yeo |
| K191346 |
02/14/2020 |
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) |
Blackrock Microsystems |
Rachelle Frischknecht |
| K193120 |
02/14/2020 |
Real Intelligence Cori |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| DEN190038 |
02/10/2020 |
Surfacer Inside-Out Access Catheter System |
Bluegrass Vascular Technologies, Inc. |
Gabriele G. Niederauer |
| K192674 |
02/18/2020 |
Mixing and Delivery System |
Bone Solutions, Inc. |
Drew Diaz |
| K192460 |
02/19/2020 |
Sentinel Cerebral Protection System |
Boston Scientific Corporation |
Eric Elliott |
| K191966 |
02/13/2020 |
NewPrim System |
BRM Extremities |
Andrea De Maglio |
| K191728 |
02/21/2020 |
ULTepap Expiratory Positive Airway Pressure (EPAP) Device |
Bryggs Medical, LLC |
Geoffrey Sleeper |
| K191532 |
02/04/2020 |
The Caterpillar and Caterpillar Micro Arterial Embolization Devices |
C. R. Bard, Inc. |
Melanie Hadlock |
| K192624 |
02/20/2020 |
ApneaTrak |
Cadwell Industries, Inc. |
James Blevins |
| K191416 |
02/07/2020 |
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack |
Caldera Medical, Inc. |
Vicki Gail |
| K192828 |
02/13/2020 |
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System |
Canon Medical Systems Corporation |
Paul Biggins |
| K192832 |
02/21/2020 |
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i |
Canon Medical Systems Corporation |
Paul Biggins |
| K192923 |
02/14/2020 |
Vitrea Software Package |
Canon Medical Systems Corporation |
Paul Biggins |
| K191202 |
02/11/2020 |
CAPENERGY - C100, C200, C300, C400, C50 |
Capenergy Medical SL |
Pilar Sanchez |
| K192662 |
02/14/2020 |
CapsoCam Plus (SV-3) Capsule Endoscopy System |
CapsoVision, Inc. |
Azimun Jamal |
| K192894 |
02/18/2020 |
Vita Flex CR System with LLI |
Carestream Health, Inc. |
Duane Gutowski |
| K191246 |
02/28/2020 |
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) |
Chalice Medical Ltd |
Carol Middleton |
| K192756 |
02/24/2020 |
Aquadex FlexFlow System 2.0 |
CHF Solutions, Inc. |
Dawn Li |
| K200228 |
02/19/2020 |
ClearCam System |
ClearCam, LLC |
Chris Idelson |
| K191536 |
02/21/2020 |
Biatain Silicone Ag |
Coloplast A/S |
Kimberly Tokach |
| K190487 |
02/18/2020 |
InPen Dose Calculator |
Companion Medical, Inc. |
Jasper Benke |
| K192841 |
02/10/2020 |
InPen System |
Companion Medical, Inc. |
Jasper Benke |
| K191785 |
02/14/2020 |
Orion LifeSpan MEG |
Compumedics Limited |
William Alam |
| K200038 |
02/05/2020 |
Endosee System |
CooperSurgical, Inc. |
Christine Kupchick |
| K190800 |
02/06/2020 |
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors |
Cosmed Srl |
Andrea Duca |
| K193232 |
02/13/2020 |
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology |
Covidien LLC |
Hilla Debby |
| K200184 |
02/21/2020 |
SmoothSkin Pure |
CyDen Limited |
Adam Stephens |
| K192000 |
02/19/2020 |
D R Burton OxyPAP |
D R Burton Healthcare, LLC |
Dennis Cook |
| K192165 |
02/11/2020 |
Acteon Imaging Suite |
de Gotzen S.R.L |
Dario Bandiera |
| K191719 |
02/20/2020 |
X-MIND Trium |
de Gotzen S.R.L |
Dario Bandiera |
| K191313 |
02/21/2020 |
Unity Subcutaneous Infusion System for Remodulin |
DEKA Research & Development |
Jason Demers |
| K192973 |
02/19/2020 |
densitas densityai |
Densitas, Inc. |
Mo Abdolell |
| K192806 |
02/05/2020 |
DENTCA Crown and Bridge |
Dentca, Inc. |
Jason Lee |
| K192688 |
02/04/2020 |
s-Clean SQ-SL Implant System Regular |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K191389 |
02/25/2020 |
Allcem Veneer APS |
Dentscare Ltda |
Roberta Uyara |
| K192855 |
02/24/2020 |
DELTA XTEND(TM) Reverse Shoulder System |
DePuy (Ireland) |
Ashley Goncalo |
| K193398 |
02/04/2020 |
Summit DuoFix HA Coating |
DePuy Orthopaedics, Inc. |
Erin Combs |
| K192749 |
02/10/2020 |
Dermadry |
Dermadry Laboratories inc. |
Maxime Calouche |
| K192273 |
02/07/2020 |
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit |
Diadent Group International |
Kab Sun Lee |
| K192158 |
02/13/2020 |
DiaTemp |
Diadent Group International |
Kab Sun Lee |
| K192022 |
02/13/2020 |
DiaTemp Flow |
Diadent Group International |
Kab Sun Lee |
| K192263 |
02/21/2020 |
UCLA CCM Abutment |
DIO Corporation |
Jiae Park |
| K193245 |
02/14/2020 |
Dunamis PunchTac Suture Anchors |
Dunamis LLC |
Prithviraj Chavan |
| K193466 |
02/16/2020 |
Swan-Ganz Catheters |
Edwards Lifesciences, LLC |
Anne Lo |
| K191890 |
02/06/2020 |
Elos Accurate Customized Abutment |
Elos Medtech Pinol A/S |
Tina Friis Poulsen |
| K191919 |
02/10/2020 |
Elos Accurate Hybrid Base |
Elos Medtech Pinol A/S |
Tina Friis Poulsen |
| K200083 |
02/14/2020 |
EMBA Hourglass Peripheral Embolization Device (PED) |
Embolic Acceleration, LLC |
Veronica McDougall |
| K191555 |
02/28/2020 |
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K200178 |
02/25/2020 |
Ez3D-i /E3 |
Ewoosoft Co., Ltd. |
Young Seok Kim |
| K193098 |
02/20/2020 |
Exactech« Equinoxe« Reverse Shoulder Glenospheres |
Exactech, Inc |
Zach Sharrah |
| K193610 |
02/06/2020 |
BreathID Smart System |
Exalenz Bioscience Ltd. |
Raffi Werner |
| K193255 |
02/20/2020 |
Largo PEEK Interbody System |
FloSpine, LLC |
Peter Harris |
| K193209 |
02/19/2020 |
Wego-Stainless Steel |
Foosin Medical Supplies Inc., Ltd. |
Zhipeng Yang |
| K192233 |
02/13/2020 |
LED Curing Light |
Foshan CICADA Dental Instrument Co., Ltd. |
Juan Liu |
| K191474 |
02/24/2020 |
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K191407 |
02/21/2020 |
Novalung System |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K192346 |
02/28/2020 |
scaffolene CL100 Bioresorbable Collagen Matrix |
Freudenberg Technology Innovation SE & Co. KG |
Denis Reibel |
| K192918 |
02/20/2020 |
Video Laparoscope, Video Processor, Light Source |
FUJIFILM Corporation |
Randy Vader |
| K191364 |
02/14/2020 |
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 |
Fujimori Kogyo Co., Ltd. |
Jeffrey Dahlen |
| K192799 |
02/21/2020 |
Glenoid Baseplate with Screw |
FX Shoulder USA, Inc. |
Kathy Trier |
| K192277 |
02/14/2020 |
CardIQ Flow |
GE Medical Systems SCS |
Elizabeth Mathew |
| K192922 |
02/20/2020 |
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter |
Gentuity, LLC |
David Kolstad |
| K193303 |
02/20/2020 |
Tinnitus Sound Generator Module |
GN Hearing A/S |
Lars Hagander |
| K192691 |
02/21/2020 |
PatCom Single-Use Introducer |
H&A Mui Enterprises Inc. |
Tammy Mui |
| K190032 |
02/27/2020 |
Disposable Sclerotherapy Needle |
Hangzhou AGS MedTech CO., Ltd |
Xiangyong Yu |
| K193152 |
02/14/2020 |
Affinity |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K192143 |
02/14/2020 |
Maximus System |
Hill-Rom Services Pte Ltd |
Alvin Tan |
| K192851 |
02/21/2020 |
OASIS MRI System |
Hitachi Healthcare Americas |
Aaron Pierce |
| K182927 |
02/07/2020 |
Pulmonary Cytology Brush |
Hobbs Medical, Inc. |
Carlos O. Acosta |
| K191828 |
02/13/2020 |
Vathin Video Bronchoscope System |
Hunan Vathin Medical Instrument Co., Ltd. |
Yun Feng |
| K192002 |
02/06/2020 |
Lucy Point-of-Care Magnetic Resonance Imaging Device |
Hyperfine Research, Inc. |
Brian Sawin |
| K192962 |
02/28/2020 |
icobrain-ctp |
Icometrix NV |
Dirk Smeets |
| K183024 |
02/13/2020 |
Implacil Implant System |
Implacil de Bortoli Material Odontologico Ltda |
Thiago Toni |
| K193498 |
02/13/2020 |
Infinitt RT PACS |
Infinitt Healthcare Co.,Ltd. |
Sang Wook Cho |
| K191529 |
02/06/2020 |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Intuitive Surgical |
Brandon Hansen |
| K191453 |
02/11/2020 |
Cervitec F |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K192545 |
02/20/2020 |
Potenza |
Jeisys Medical Incorporated |
Wonchel Choi |
| K192677 |
02/18/2020 |
Safety Insulin Pen Needle |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K190842 |
02/03/2020 |
Comus Locking Plate systems |
Jiangsu Trauhui Medical Instrument Co.,Ltd. |
Zhou Yu |
| K200161 |
02/21/2020 |
3MP Monochrome Digital Mammography LCD Monitor MS-S300 |
Jvckenwood Corporation |
Hideki Tengeiji |
| K193203 |
02/18/2020 |
MOJAVE Expandable Interbody System |
K2M, Inc. |
Oonagh Lahiff |
| K193129 |
02/07/2020 |
Yukon OCT Spinal System |
K2M, Inc. |
Oonagh Lahiff |
| K191858 |
02/24/2020 |
Pylant Monitor |
Kal-Med LLC |
Sandra Greenwood |
| K190966 |
02/03/2020 |
Katalyst Training System |
Katalyst Inc. |
Bjoern Woltermann |
| K193324 |
02/04/2020 |
Motion Correction System |
KinetiCor, Inc. |
Doug Donzelli |
| K191832 |
02/04/2020 |
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) |
Kurin, Inc |
Neal Hartman |
| K193320 |
02/04/2020 |
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System |
Kyocera Medical Technologies, Inc. |
Anthony DeBenedictis |
| K191235 |
02/12/2020 |
Leltek Ultrasound Imaging System |
Leltek Inc |
Kiefe Chang |
| K190882 |
02/13/2020 |
XenoSure Biologic Patch |
LeMaitre Vascular |
John N. Bradsher |
| K193521 |
02/06/2020 |
Steerable Plateau Ti |
Life Spine, Inc. |
Angela Batker |
| K191030 |
02/21/2020 |
Applied BiosystemsÖ 3500 Dx Genetic Analyzer and Applied BiosystemsÖ 3500xL Dx Genetic Analyzer |
Life Technologies Corporation |
Darcie Baynes |
| K193475 |
02/14/2020 |
OneTouch Verio Reflect Blood Glucose Monitoring System |
LifeScan Europe GmbH |
Niki Skelly |
| K200148 |
02/21/2020 |
LightForce Orthodontic System (LFO System) |
LightForce Orthodontics |
Amos N Benninga |
| K191402 |
02/25/2020 |
Heater-Cooler System 3T |
LivaNova Deutschland GmbH |
Scott Light |
| K193644 |
02/14/2020 |
E-COM DR-2000 DR |
LiverMoreTech, Inc. |
Jay Kim |
| K190909 |
02/13/2020 |
ArtiSential Bipolar Fenestrated Forceps |
Livsmed Inc. |
Dong Wook Lee |
| K192247 |
02/28/2020 |
Steripath Gen2 Blood Collection System |
Magnolia Medical Technologies, Inc. |
Gregory J Bullington |
| K193128 |
02/02/2020 |
Mako Total Hip Application |
Mako Surgical Corp. |
Liza Gordillo |
| K193242 |
02/27/2020 |
Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories |
Masimo Corporation |
Sindura Penubarthi |
| K193416 |
02/28/2020 |
Cellvizio I.V.E. with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K200130 |
02/10/2020 |
M.U.S.T. MINI Posterior Cervical Screws System |
Medacta International SA |
Stefano Baj |
| K193165 |
02/10/2020 |
MectaFix CL Fixation Button with Continuous Loop |
Medacta International SA |
Stefano Baj |
| K193461 |
02/06/2020 |
MectaLock All-Suture Anchors |
Medacta International SA |
Stefano Baj |
| K193554 |
02/16/2020 |
APTUS« Forearm Shaft Plates and APTUS« Wrist 2.5 System |
Medartis AG |
Andrea Kiefer-Schweizer |
| DEN190020 |
02/25/2020 |
iTind System |
Medi-Tate Ltd. |
Lihi Liviatan |
| K200132 |
02/18/2020 |
Ashvins |
MedicalCommunications GmbH |
Martin Schinkmann |
| K200225 |
02/28/2020 |
Arctic Sun Stat Temperature Management System |
Medivance, Inc. |
Jacquelyn Borinski |
| K192820 |
02/28/2020 |
SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Matt Clausen |
| K192804 |
02/27/2020 |
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm |
Medos International SARL |
Michael Liao |
| K192414 |
02/13/2020 |
Praxiject 0.9% NaCl |
MedXL Inc. |
Premala Premanathan |
| K192614 |
02/13/2020 |
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment |
MegaGen Implant CO., Ltd. |
You Jung Kim |
| K191462 |
02/27/2020 |
Proov Test |
MFB Fertility, Inc. |
Amy Beckley |
| K191829 |
02/13/2020 |
Microlife Non-Contact Infrared Forehead Thermometer |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K191689 |
02/13/2020 |
EleGARD Patient Positioning System |
Minnesota Resuscitation Solutions, d.b.d AdvancedCPR Solutio |
Philip Tetzlaff |
| K200079 |
02/13/2020 |
ClearPoint System and Accessories |
MRI Interventions, Inc |
Pete Piferi |
| K192447 |
02/28/2020 |
Superelastic Staple |
Neosteo |
Anne-Cecile Grandremy |
| K193412 |
02/24/2020 |
NEXXT MATRIXX System |
Nexxt Spine LLC |
Andy Elsbury |
| K191975 |
02/07/2020 |
Elefix V Paste for EEG & EMG |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K193506 |
02/26/2020 |
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System |
NuVasive Incorporated |
Aditya Sharma |
| K193414 |
02/25/2020 |
Trigon HA Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K180935 |
02/05/2020 |
Infinity / Infinity Cross Flex Dental Systems |
Olsen Insdustria de Equipamentos Odontomedicos |
Ana Claudia Espindola |
| K190363 |
02/21/2020 |
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage |
Omnia Medical, LLC |
Troy Schifano |
| K192096 |
02/27/2020 |
Omnia Medical Trauma Screws |
Omnia Medical, LLC |
Troy Schifano |
| K192785 |
02/05/2020 |
OptiScanner« 5000 Glucose Monitoring System |
Optiscan Biomedical Corporation |
Charles Zimliki |
| K200236 |
02/25/2020 |
VITROS BRAHMS PCT Reagent Pack and Calibrators |
Ortho Clinical Diagnostics |
Ann M Quinn |
| K193472 |
02/13/2020 |
OrthoCircle Spine Pedicle Screw System |
OrthoCircle Spine |
Jack Mathews |
| K191946 |
02/27/2020 |
Penumbra System Penumbra JET 7X |
Penumbra, Inc. |
Micaela Victoria |
| K193103 |
02/07/2020 |
NeoBase 2 Non-derivatized MSMS Kit |
PerkinElmer Inc. |
Eva Nalian |
| K190682 |
02/27/2020 |
Explorer Mini |
Permobil AB |
Ivan Fernandez |
| K200179 |
02/18/2020 |
Collaboration Live |
Philips Healthcare |
Paul Elias |
| K191740 |
02/21/2020 |
DORO LUCENT« iXI and iMRI Headrest System |
Pro Med Instruments GmbH |
Sandra Untenberger |
| K191646 |
02/21/2020 |
Beamscan MR |
PTW-Freiburg Physikalisch-Technische-Werkstaetten |
Sandor-Csaba Ats |
| K191737 |
02/14/2020 |
The Graft Bone Substitute |
Purgo Biologics Inc. |
Eun Ho Kim |
| K193243 |
02/28/2020 |
Alta Multipurpose Device |
Qfix |
Alexandra Low Smythe |
| K190304 |
02/29/2020 |
Kingon P2 Oxygen Concentrator |
Qingdao Kingon Medical Science and Technology Co. |
Roman Huang |
| K192557 |
02/13/2020 |
Youjia Unscented Tampon with Plastic Applicators |
Qingdao Youjia Hygiene Technology Co., Ltd |
Huiying Zhao |
| K192600 |
02/21/2020 |
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 |
quanta system spa |
Francesco Dell'Antonio |
| K200234 |
02/25/2020 |
Surgical laser fibers |
Quanta System Spa |
Francesco DellÆAntonio |
| K193012 |
02/19/2020 |
speX Support Catheter |
ReFlow Medical |
Krystal Santiago |
| K193596 |
02/20/2020 |
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 |
Reflow Medical |
Krystal Santiago |
| K200284 |
02/28/2020 |
R-Sensor, R-Sensor |
Remedi Co. Ltd. |
Jadon Koo |
| K192127 |
02/05/2020 |
Respire Pink AT (Hard, Hard/Soft, EF) |
Respire Medical Holdings |
Madubuike Okafor |
| K192527 |
02/07/2020 |
Rochal Antimicrobial Wound Gel |
Rochal Industries, LLC |
William J. Coulston |
| K193313 |
02/27/2020 |
Elecsys Anti-TSHR |
Roche Diagnostics |
Reanna Toney |
| K192072 |
02/21/2020 |
Tina-quant C-Reactive Protein IV |
Roche Diagnostics Operations (RDO) |
Barbara Ann McWhorter |
| K200065 |
02/10/2020 |
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Kaitlyn Hameister |
| K193274 |
02/27/2020 |
Rodo Abutment System |
RODO Medical, Inc. |
James Park |
| K192619 |
02/27/2020 |
Pitkar Locked Plating System |
S H Pitkar Orthotools Pvt Ltd. |
Vivek Mangalwedhekar |
| K192381 |
02/18/2020 |
DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor |
Scientific Pharmaceuticals |
Thomas Kelly |
| K190406 |
02/20/2020 |
SDS2.2 dental implant |
SDS Swiss Dental Solutions AG |
Martin Chares |
| K193224 |
02/13/2020 |
Daytona« Small Stature Growth Rod Conversion Set |
SeaSpine Orthopedics Corporation |
Jesse Albright |
| K200381 |
02/28/2020 |
Daytona« Small Stature Spinal System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K200016 |
02/25/2020 |
uCT 530, uCT 550 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K191347 |
02/07/2020 |
Paragon XHD Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co., Ltd. |
Jiang Xiaosan |
| K191894 |
02/21/2020 |
Upper Arm Blood Pressure Monitor |
ShenZhen ZhengKang Technology Co., Ltd. |
Huayong Yang |
| K200189 |
02/26/2020 |
Luna Dental Implant System- Healing Abutment |
Shinhung MST Co., Ltd. |
Jae Soo Song |
| K193489 |
02/13/2020 |
ADVIA Centaur BR |
Siemens Healthcare Diagnostics Inc. |
Ian Thompson |
| K193178 |
02/12/2020 |
Biograph Horizon |
Siemens Medical Solution USA, Inc. |
Alaine Medio |
| K192496 |
02/28/2020 |
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit |
Siemens Medical Solutions USA Inc. |
Cordell L Fields |
| K193248 |
02/14/2020 |
Biograph Vision, Biograph mCT Family of PET/CTs |
Siemens Medical Solutions USA, Inc |
Tabitha Estes |
| K192876 |
02/27/2020 |
INTELLIO Tablet Application |
Smith & Nephew |
Janice Haselton |
| K193029 |
02/28/2020 |
CONQUEST FN |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K192253 |
02/25/2020 |
SonicEye Dual-Array Ultrasound System |
Sonivate Medical Inc |
Steve Hesler |
| K193396 |
02/05/2020 |
PERLA« TL posterior osteosynthesis system |
Spineart |
Franck Pennesi |
| K200170 |
02/05/2020 |
SpineNet SSP System |
SpineNet LLC |
King Floyd |
| K200117 |
02/07/2020 |
Trevo NXT ProVue Retriever |
Stryker |
Germaine Fu |
| K193118 |
02/21/2020 |
TGS Guidewire and updated Scopis Software |
Stryker ENT |
Bruce Backlund |
| K193502 |
02/14/2020 |
TGS Universal Headrest with Mounting Arm |
Stryker ENT |
Denise Thompson |
| K200206 |
02/27/2020 |
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter |
Stryker Neurovascular |
Shazia Hakim |
| K193308 |
02/23/2020 |
T2 Alpha Tibia Nailing System, IMN Screws System |
Stryker Trauma GmbH |
Sanja Jahr |
| K193587 |
02/10/2020 |
Sutter Swyng non-stick bipolar forceps, single-use |
Sutter Medizintechnik GmbH |
Ulrike Zeissler |
| K191463 |
02/26/2020 |
DePuy Synthes Hammertoe Continuous Compression Implant |
Synthes (USA) Products, LLC |
Keith Knapp |
| K190919 |
02/27/2020 |
ST Internal Implant System |
T-Plus Implant Tech. Co., Ltd. |
Dana Cheng |
| K193483 |
02/28/2020 |
Basal-IQ Technology |
Tandem Diabetes Care, Inc. |
Trevor J Dendo |
| K190962 |
02/03/2020 |
Bella-mu |
U-Needle B.V. |
Gert Veldhuis |
| K192596 |
02/11/2020 |
ULab Systems Dental Aligner Kit |
uLab Systems, Inc. |
Charlie Wen |
| K192203 |
02/10/2020 |
JO for Him H2O Gel Original Personal Lubricant |
United Consortium |
Stephanie Morris |
| K192377 |
02/10/2020 |
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon |
Varian Medical Systems, Inc. |
Peter J Coronado |
| K200182 |
02/11/2020 |
EzRay Air Portable (Model: VEX-P300) |
Vatech Co., Ltd |
Daniel Kim |
| K192120 |
02/14/2020 |
Venner PneuXÖ ETT (Endotracheal Tube) 6 mm, Venner PneuXÖ ETT (Endotracheal Tube) 7 mm, Venner PneuXÖ ETT (Endotracheal Tube) 8 mm, Venner PneuXÖ ETT (Endotracheal Tube) 9 mm |
Venner Medical (Singapore) Pte Ltd |
Adrian P Waterton |
| K192757 |
02/06/2020 |
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor û bag of 20, VitalPatch 7D Biosensor û bag of 20 |
VitalConnect, Inc. |
Cynthia Merrell |
| K200247 |
02/27/2020 |
Fusion Quattro Extraction Balloon |
Wilson-Cook Medical, Inc |
Tiffanny A Thomas |
| K192579 |
02/03/2020 |
X-Guide Surgical Navigation System |
X-Nav Technologies, LLC |
Fred Cowdery |
| K191928 |
02/28/2020 |
AccuContour |
Xiamen Manteia Technology LTD. |
Lu Xie |
| K191571 |
02/06/2020 |
UV Radiation Treatment System |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
Kai Li |
| K193550 |
02/28/2020 |
Therm-X |
Zenith Technical Innovations |
Greg Binversie |
| K193180 |
02/24/2020 |
Alliance Augmented Glenoid |
Zimmer Inc. |
Patricia Sandborn Beres |
| K192660 |
02/28/2020 |
Zimmer M/L Taper Hip Prosthesis |
Zimmer, Inc. |
Caleb Barylski |
| K191697 |
02/21/2020 |
Cardiac Monitor 1500 |
Zynex Medical, Inc. |
Thomas Sandgaard |
