FDA 510(k) Decisions During May, 2020  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K193085 05/11/2020 PuraDERM Gel 3-D Matrix, Inc. Lisa Spirio
K193055 05/13/2020 Purzir Dental Zirconia 3DBioCAD Gyu D. Cho
K191362 05/20/2020 LifeFlow Blood System 410 Medical, Inc. Galen Robertson
K193293 05/14/2020 XV Lung Ventilation Analysis Software 4Dx Limited Terrence Thiel
K200002 05/29/2020 Anterior Spine Truss System û Stand Alone (ASTS-SA) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K192887 05/04/2020 Revitive Medic Plus, Revitive Advanced 2 Actegy, Ltd. Lawrence Brookfield
K200944 05/26/2020 UNIEXPERT 2 PLUS Adani Vladimir Linev
K191847 05/22/2020 Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps Adeor Medical AG Florian Gehrmann
DEN190031 05/11/2020 NP Screen Advance Sentry Corporation Leo Chui
K200950 05/08/2020 Ventricular Catheter Aesculap, Inc. Kathy A. Racosky
K200659 05/09/2020 Dermalux Tri-Wave MD Aesthetic Technology Ltd. Dale Needham
K192016 05/19/2020 SMOOV O10 Alber GmbH Michael Vent
K200035 05/04/2020 Ultravision Visual Field Clearing System Alesi Surgical Ltd. David Broderick
K200995 05/21/2020 InsigniaÖ Anterior Cervical Plate System Alphatec Spine, Inc. Sandy Gill
K200936 05/22/2020 InvictusÖ CT Spinal Fixation System Alphatec Spine, Inc. Ruby Zheng
K200056 05/18/2020 Catalys Precision Laser System AMO Manufacturng USA, LLC Laarni Ricafort
K190559 05/22/2020 SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports AngioDynamics, Inc. Vidyalakshmi Jayaraman
K192048 05/14/2020 Single Use Endoscope Valves Set Anrei Medical (Hangzhou) Co., Ltd. Yang HuiBing
K201106 05/21/2020 IntraMarX 3D Radiopaque Marker AnX Robotica Corp. Steven Gu
DEN190037 05/22/2020 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule AnX Robotica, Inc. David Duan
K192244 05/11/2020 Arcad SmileStudio and Aligner System ArcadLab Emerson Cano
K201112 05/27/2020 AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP Arrow International Inc. Shajunath Nirupama
K200352 05/20/2020 Axis Spine Technologies ALIF Axis Spine Technologies Ltd Edwin Lindsay
K192577 05/07/2020 Actreen Hi-Lite Intermittent Urinary Catheters B. Braun Medical Inc. Anita J. Nemeth
K192930 05/12/2020 Dymaxeon Spine System Back 2 Basics Direct, LLC Lou Keppler
K200870 05/01/2020 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Jocelyn Kersten
K200640 05/08/2020 ALTAPORE SHAPE Baxter Healthcare Corporation Phillip Romei
K193553 05/18/2020 VarseoSmile Temp BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG Tanja Gotz
K192295 05/01/2020 PDT-FACE Beijing ADSS Development Co., Ltd. Su CuiYing
K191826 05/14/2020 KeYi Total Hip System Beijing KeYi Medical Device Technology Co., Ltd. Jenny Jiang
K192446 05/21/2020 CO2 Mainstream Module Beijing Kingst Commercial & Trade Co.,Ltd. Judong Gao
K192488 05/22/2020 CO2 Sidestream Module Beijing Kingst Commercial & Trade Co.,Ltd. Judong Gao
K193185 05/04/2020 Anscare SIMO Negative Pressure Wound Therapy (NPWT) System BenQ Materials Corporation Miranda Chang
K193122 05/15/2020 Biocore9 Humeral Resurfacing System Biocore9, LLC. Stan Matlak
K200512 05/07/2020 ETEST Plazomicin (PLZ) (0.016-256 ?g/mL) bioM?rieux S.A. Alexia Bosquet
K201178 05/29/2020 iLab Polaris Multi-Modality Guidance System Boston Scientific Kevin Lam
K200483 05/21/2020 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller Boston Scientific Corporation Inderdeep Tiwana
K192692 05/28/2020 Brainomix 360 e-CTA Brainomix Limited Gwilym Owen
K200435 05/07/2020 Catalyst+, Catalyst+ HD C-Rad Positioning AB Thomas Matzen
K201111 05/26/2020 GentleMax Pro Plus Candela Corporation Yverre Bobay
K200274 05/21/2020 CariCloud Caristo Diagnostics James Davis
K200457 05/22/2020 Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming CC Wellness LLC Marlent Perez
K193441 05/26/2020 Aqua Naina Sterile Saline Solution Chemtex USA, Inc. Haribabu Talasila
K192642 05/13/2020 308nm Excimer System Chongqing Peninsula Medical Technology Co., Ltd. Zhang Sudi
K200920 05/29/2020 Idys ALIF ZP 3DTi Clariance, SAS Fadwa Bahr
K200871 05/04/2020 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator Control Medical Technology Shawn Fojtik
K200629 05/29/2020 Aspire Mechanical Aspirator G Control Medical Technology Shawn Fojtik
K201086 05/21/2020 Advincula Delineator Uterine Manipulator CooperSurgical, Inc. Kyle Hooper
K193220 05/05/2020 AVIEW LCS Coreline Soft Co., Ltd Hyeyi Park
K200395 05/07/2020 LOSPA II Knee System (EXULT Knee Replacement System) Corentec Co., Ltd Sungwon Yang
K192656 05/01/2020 Optimized Positioning System (OPS) Insight Corin USA Lucinda Gerber
K200146 05/07/2020 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor Covidien, llc Shani Frenkel
K200700 05/14/2020 Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter Creagh Medical Ltd. Amy Yanta
K193043 05/11/2020 Critical Alert CommonPath Enterprise Critical Alert John Elms
K200991 05/13/2020 EVOL Spinal Interbody System Cutting Edge Spine, LLC Kyle Kuntz
K192262 05/29/2020 Dental Zirconia Blocks De Corematrix Co.Ltd. Kaixuan Liu
K193496 05/06/2020 CharmFil Dentkist, Inc. Shin Haeng Lee
K192392 05/26/2020 DiaPlus Diadent Group International Kab Sun Lee
K192586 05/06/2020 LIAISON« Folate Diasorin Inc. John C. Walter
K193404 05/18/2020 UF(II) Bar holder abutment DIO Corporation JiAe Park
K201124 05/19/2020 TOPAZ Mobile DR System DRGEM Corporation Ki-Nam Yang
K192069 05/06/2020 Aerodentis System Dror Orthodesign Michael Nadav
K192879 05/21/2020 Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System Edan Instruments, Inc Melody Huang
K191590 05/05/2020 AA temp temporary restoration 3D printing photoreactive resin Enlighten Materials Co., Ltd Jiun Ming Su
K200253 05/27/2020 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
K200841 05/11/2020 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 Ethicon Endo-Surgery, Llc Nathan Anderson
K200169 05/14/2020 VFS1 Bipolar Electrosurgical Generator FHC, Inc. Kelly Moeykens
K201131 05/28/2020 firefly T-2 Firstkind Limited Neil Buckley
K181691 05/26/2020 High-speed air turbine handpiece / Low-speed air turbine handpiece Foshan Wenjian Medical Instrument Co., Ltd. Wen Huang
K192209 05/08/2020 Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K192286 05/01/2020 FUJIFILM EP-6000 Video Processor FUJIFILM Corporation Randy Vader
K200964 05/08/2020 Sonosite PX Ultrasound System FUJIFILM SonoSite, Inc. Sudipta Chakrabarti
K200997 05/14/2020 Lumipulse G CA19-9-N Fujirebio Diagnostics, Inc. Kristin Maddaloni
K200479 05/15/2020 AquaPulse Auxiliary Water Connector GA Health Company Limited Cindy Ye
K193334 05/15/2020 Pristina Serena Bright GE Healthcare Barthelemy Arman
K192633 05/01/2020 GUS831 Compressor Nebulizer Globalcare Medical Technology Co., Ltd. Janice Deng
K190118 05/13/2020 Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) Guangzhou Xinbo Electronic Co., Ltd. Sammy Li
K200305 05/26/2020 NPseal Guard Medical Inc. Machiel Van der Leest
K193516 05/04/2020 Sonata« Sonography-Guided Transcervical Fibroid Ablation System 2.1 Gynesonics, Inc Diane King
K191512 05/21/2020 LotusCatheter (Lotus No Balloon Catheter) Hakki Medical Technologies, Inc. Shereen Said Hakky
K193228 05/04/2020 Hamilton-G5 Hamilton Medical AG Simone Haller
K192342 05/21/2020 Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) Hangzhou AGS MedTech Co., Ltd. Chunqi Han
K200173 05/01/2020 Stone Retrieval Balloon Hangzhou AGS MedTech Co., Ltd. Chunqi Han
K193189 05/06/2020 RFID Localization System Health Beacons, Inc. Nancy Confrey
K200988 05/26/2020 Maximus System Hill-Rom Services Pte Ltd Alvin Tan
K200866 05/17/2020 Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) Hologic, Inc. Anila Tarte
K200782 05/13/2020 Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite Howmedica Osteonics Corp. Nora O'Connor
K193233 05/27/2020 Restoration« Modular Hip System Howmedica Osteonics Corp. (aka Stryker Orthopaedics) Nora O'Connor
K200846 05/05/2020 BalteumÖ Lumbar Plate System Huvexel Co., Ltd Sung Kyu Hur
K200966 05/07/2020 Icare HOME Tonometer Icare Finland Oy Hannes Hyvonen
K200235 05/29/2020 KONG-TL VBR System, KONG-C VBR System icotec ag Marina Hess
K193423 05/22/2020 VADER«one Pedicle System MIS and LightMore« Pedicle System 6.0 Icotec AG Marina Hess
K192218 05/08/2020 Custom Legacy and Custom InterActive Titanium Abutments Implant Direct Sybron Manufacturing , LLC Reina Choi
K192399 05/20/2020 Infinity Angioplasty Balloon Catheter Infinity Angioplasty Balloon Company, LLC Tiffini Wittwer
K200293 05/05/2020 InMode System with vTone Applicator InMode Ltd. Amit Goren
K192652 05/27/2020 TRV Interacoustics A/S Erik Nielsen
K201043 05/12/2020 Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) iRay Technology Taicang Ltd. Junjie Qian
K201004 05/01/2020 Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W iRay Technology Taicang Ltd. Meng Li
K192405 05/01/2020 Image Guidance System for Radiotherapy Jiangsu Rayer Medical Technology Co., Ltd. Peng Li
K192449 05/27/2020 Joline Kyphoplasty System Allevo Joline GmbH & Co. KG Peter Kohlbecher
K200419 05/22/2020 Kalera Vacuum Aspiration Catheter (K-VAC) Kalera Medical, Inc. Jee Shin
K192727 05/20/2020 K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) Kamiya Biomedical Company Shawn Kaplan
K200390 05/18/2020 V.A.C. DERMATAC Drape KCI USA, Inc Margaret Marsh
K192540 05/01/2020 Kitazato ET Catheters Kitazato Corporation Futoshi Inoue
K192420 05/29/2020 Crownjun Nylon Suture Kono Seisakusho Co., Ltd. Hiroyuki Arai
K201184 05/05/2020 Lascod Impression Materials Lascod Spa Gualtiero Cozzi
K200287 05/15/2020 BP-BT Kiosk LD Technology LLC Albert Maarek
K183110 05/04/2020 LIVIA LifeCare Ltd. Amnon Nahum Sharon
K193539 05/28/2020 REVOLVE ENVI 600 Advanced Adipose System LifeCell Corporation Bozhana Hegarty
K200653 05/07/2020 AMF Revision TT Cones LimaCorporate S.p.A Roberto Gabetta
K193535 05/07/2020 EZER, Portable X-ray System Livermoretech Inc. Jae Hong Kim
K200501 05/11/2020 ArtiSential Laparoscopic Instrument-Electrodes LivsMed Inc. Dong Wook Lee
K193602 05/29/2020 LV Liberty Vision Model 1 90Yttrium Brachytherapy Source LV Liberty Vision Corporation Paul T. Finger
K200860 05/20/2020 HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) M.I. Tech Co., Ltd Inae Kim
K200910 05/02/2020 BOSS Balloon Guide Catheter Marblehead Medical Kristin Mortenson
K191334 05/29/2020 Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 MATIA Robotics (US) Inc Necati Hacikadiroglu
K200935 05/08/2020 Mazor X Mazor Robotics Ltd. Shiran Conforti
K200749 05/19/2020 CUBEScan BioCon-900S Mcube Technology Co., Ltd. Hye-Ri Choi
K201136 05/12/2020 CureÖ Lumbar Plate System Meditech Spine, LLC Bruce Dunaway
K192283 05/06/2020 MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator Medron, LLC David Kujawa
K200511 05/29/2020 ROSA ONE Brain application Medtech S.A. Serge Tabet
K191745 05/15/2020 Medtronic Commander Flex Medtronic Care Management Services Gordon Nelson
K201189 05/29/2020 Stealthstation S8 Spine Software v1.3.0 Medtronic Navigation, Inc. Jason Woehrle
K201068 05/21/2020 Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface Medtronic, Inc. Sammie C. Joseph-Fredericks
K201118 05/26/2020 Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level Medtronic, Inc. Jen Correa
K201011 05/13/2020 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Alexandra Theisen
K193457 05/12/2020 AUDERE Lumbar Spacer System Met One Technologies Kyle Atwood
K192694 05/14/2020 PAL Single-Use Cannulas MicroAire Surgical Instruments Glenn Gerstenfeld
K191906 05/18/2020 MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF MiRus, LLC Jordan Bauman
K201172 05/29/2020 CFP-3131, CFP-2222 MX Imaging, Inc. John Ross
K200878 05/18/2020 Natus NeuroWorks Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K200348 05/08/2020 Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) Neocis Inc. Thomas E. Claiborne
K200124 05/13/2020 InCore MPJ System Nextremity Solutions, Inc. Elise Fox
K200969 05/21/2020 NEXXT MATRIXX System Nexxt Spine LLC Andy Elsbury
K192693 05/07/2020 Nuvo Nano Portable Oxygen Concentrator Nidek Medical Products, Inc. Olivia Mullen
K200737 05/21/2020 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K193016 05/08/2020 PRECICE Bone Transport System NuVasive Specialized Orthopedics, Inc. Madison Heffron
K193617 05/08/2020 Precice« Screws NuVasive Specialized Orthopedics, Inc. Madison Heffron
K200956 05/21/2020 NuVasive Thoracolumbar Plates NuVasive, Incorporated Daniela Mahan
K201078 05/20/2020 NuVasive« ACP System NuVasive, Incorporated Ivanna Lopez
K200914 05/05/2020 Healix Compression Screw System Nvision Biomedical Technologies, Inc Diana Langham
K200546 05/05/2020 ZeeroMED View O3 Enterprise SRL Andrea Poli
DEN190026 05/01/2020 iTEAR Neurostimulator Olympic Ophthalmics, Inc. Michael Gertner
K192103 05/11/2020 Thunderbeat Open Fine Jaw Type X Hand Instrument Olympus Medical Systems Corp. Toshiyuki Nakajima
K200246 05/22/2020 JPS JuniOrtho Plating System Orthofix Srl Gianluca Ricadona
K200606 05/01/2020 O-Genesis Graft Delivery System Orthofix, Inc. Troy Brooks
K200259 05/04/2020 Headless Compression Screw System OsteoCentric Extremities, LLC Todd Evans
K192981 05/28/2020 Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 Penumbra, Inc Teri Nguyen
K200279 05/01/2020 ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine Phadia AB Carina Magnusson
K200410 05/22/2020 Reconnaissance PV .018 OTW Digital IVUS Catheter Philips Image Guided Therapy Corporation Mary Stanners
K192914 05/27/2020 Stimuplex Onvision System Philips Medical Systems Nederland B.V. Gert de Vries
K200917 05/01/2020 Azurion R2.1 Philips Medical Systems Nederland BV Michelle Campbell
K201053 05/14/2020 PercuNav Image Fusion and Interventional Navigation Philips Ultrasound, Inc Travis Catania
K201012 05/01/2020 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System Philips Ultrasound, Inc. Deep Pal
K192222 05/12/2020 EZ-Inject Single use Needle POONGLIM Pharmatech Inc. Cho Hee Min
K200303 05/19/2020 Reform Pedicle Screw System Precision Spine Micheal C. Dawson
K200317 05/14/2020 Support Catheter QXMedical, LLC Fernando Di Caprio
K201058 05/06/2020 Accuvue+ Radmedix LLC Gabriel Issa
K192418 05/27/2020 Phacoemulsification Needle (Tip) and Irrigation Sleeve Raico LLC Ravi Nallakrishnan
K200032 05/26/2020 ReWalk P6.0 ReWalk Robotics Ltd. Ofir Koren
K200984 05/27/2020 Guardian Needle Electrode Rhythmlink International, LLC Gabriel Orsinger
K200417 05/02/2020 RIST Radial Access Catheter RIST Neurovascular, Inc. Marianne Grumwaldt
K193096 05/14/2020 S.I.N. Dental Implant System S.I.N. -Sistema de Implante Nacional S.A. Denise Domiciano
K201120 05/27/2020 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card Safecare Biotech(Hangzhou)Co.,Ltd. Alex Qiu
K200699 05/07/2020 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K200885 05/28/2020 Meridian Anterior Plate System, Regatta Lateral Plate System SeaSpine Orthopedics Corporation Aly Alvarez
K200290 05/11/2020 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) SeaSpine Orthopedics Corporation Caryn Sailor
K192560 05/22/2020 Surgical Gown Shandong Kangli Medical Equipment Technology Co., Ltd. Zhuang Liu
K200751 05/21/2020 Photodynamic Therapy (PDT) Equipment Shangdong Huamei Technology Co., Ltd. Xu QingHua
K200746 05/15/2020 IPL Treatment Systems Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K200116 05/28/2020 PicoSecond Nd: YAG Laser System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K192179 05/01/2020 Oral/Enteral Syringe Shanghai Kindly Enterprise Development Group Co., Ltd Weixin Zhang
K193176 05/05/2020 uMR 780 Shanghai United Imaging Healthcare Co., Ltd Xin Gao
K200864 05/19/2020 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K200026 05/12/2020 Disposable ECG Cable Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K193391 05/21/2020 BeneVision Central Monitoring System Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K200979 05/28/2020 DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shi Jufang
K192972 05/07/2020 Patient Monitor Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K200509 05/29/2020 ADVIA Centaur Vitamin D Total (VitD) Siemens Healthcare Diagnostics Inc. Paul DaSilva
K201130 05/26/2020 ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Hyunjung Lee
K201034 05/14/2020 Syngo.CT CaScoring Siemens Medical Solutions USA, Inc. Tabitha Estes
K200213 05/11/2020 Biograph mMR with syngo MR E11P-AP01 system software Siemens Medical Solutions, USA, Inc. Cordell L. Fields
K201062 05/18/2020 syngo Ultrasound Apps Suite (sUSAS) Siemens Medical Solutions, USA, Inc. Christine Dunbar
K192866 05/07/2020 Chemfort CSTD Simplivia Healthcare Ltd. Itsik Shmueli
K200367 05/14/2020 Distal Humerus Plating System Skeletal Dynamics, Inc. Ana M. Escagedo
K200701 05/14/2020 Skeletal Dynamics Midshaft Humerus Plating System Skeletal Dynamics, Inc. Diana Taylor
K193460 05/26/2020 The iNAP One Sleep Therapy System Somnice, Inc. Sujith Shetty
K193058 05/15/2020 SonarMed AirWave Airway Monitoring System SonarMed, Inc. Laura Lyons
K192651 05/07/2020 ZAGA Zygomatic System Southern Implants (Pty) Ltd Lauranda G Breytenbach
K200571 05/01/2020 PERLA« Posterior Occipito-Cervico-Thoracic Fixation System SPINEART Franck Pennesi
K200989 05/14/2020 Reliance Endoscope Processing System STERIS Corporation Jennifer Nalepka
K200126 05/22/2020 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation Anthony Piotrkowski
K200252 05/21/2020 Getinge Assured MI Steam Migrating Integrator SteriTec Products MFG Co Inc Jonathan Rutigliano
K200205 05/13/2020 Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled Stryker Sustainability Solutions Mia McCorkel
K200431 05/18/2020 3D GraftRasp System SurGenTec Andrew Shoup
K193336 05/27/2020 Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse Synedgen, Inc. Shenda Baker
K200933 05/05/2020 Syntec Non-Sterile Steinmann Pins System Syntec Scientific Corporation Nicole Tseng
K200400 05/21/2020 Systane iLux2 Tear Film Innovations, Inc. Neal Hartman
K200747 05/15/2020 PuriLens Plus Preservative Free Saline The LifeStyle Company, Inc. Tom Seidner
K193420 05/06/2020 XO Cross Support Catheter Transit Scientific Jenifer Arnold
K193495 05/29/2020 XO Score Percutaneous Transluminal Angioplasty Scoring Catheter Transit Scientific Jennifer Arnold
K200961 05/08/2020 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. Rachel Osbeck
K192265 05/21/2020 gi-4000 Electrosurgical Generator United States Endoscopy Group, Inc Carroll L. Martin
K200120 05/07/2020 LiteSaber Wire Torque Assist Device Vesatek, LLC David Look
K200468 05/21/2020 V30 system, V20 system, V10 system, V-FC Handpiece Viora Ltd. Simona Forman Krant
K193436 05/14/2020 VITA Ambria VITA Zahnfabrik GmbH H Rauter & Co Bernd Walker
K200525 05/27/2020 Medical Diode Laser Hair Removal System Weifang Mingliang Electronics CO., LTD Li MingLiang
K191819 05/14/2020 Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border Winner Medical Co., Ltd. Dan Wang
K192463 05/14/2020 PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border Winner Medical Co., Ltd. Dan Wang
DEN180065 05/01/2020 OGmend Implant System Woven Orthopedic Technologies, LLC Bob Luzzi
K200662 05/21/2020 X-Guide« Surgical Navigation System X-Nav Technologies,LLC. Fred Cowdery
K190982 05/29/2020 Automatic Digital Blood Pressure Monitor Xiamen Ants Bro Technology Co., Ltd. Jane Xu
K193665 05/28/2020 Frozen N Yozma BmTech Co., Ltd. Jenny Cho
K200453 05/01/2020 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
K192901 05/12/2020 HealthVCF Zebra Medical Vision Ltd. Flair Bar
K200315 05/05/2020 Ziostation2 Ziosoft, Inc. Tsuyoshi Nagata


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