FDA 510(k) Decisions During February, 2020  

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


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