FDA 510(k) Decisions During June, 2020  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K192550 06/05/2020 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H 3M Company Hilary B Hovde
K200536 06/01/2020 3MTM AttestTM Rapid 5 Steam-Plus Test Pack 3M Complany Mary Fretland
K200721 06/03/2020 Agilis HisPro Steerable Catheter With Electrodes Abbott (St. Jude Medical) Winnie Yik
K193371 06/12/2020 FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care Inc. Naveen Thuramalla
K201148 06/26/2020 EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License Abbott Medical Alyssa Timmers
K201181 06/26/2020 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System Abbott Medical Charlie Pickrell
K201116 06/15/2020 Abiomed 23 Fr Sheath Abiomed Inc. Sandy Fowler
K201220 06/17/2020 Aerus Medical Guardian,model F170A Aerus Medical LLC Andrew Eide
K193298 06/19/2020 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
DEN200026 06/15/2020 EndeavorRx Akili Interactive Labs Inc. Scott Kellogg
K200322 06/02/2020 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K200532 06/02/2020 StarPore Anatomics Pty, Ltd. Christine Scifert
K192864 06/01/2020 UNI*FUSE Infusion System with Cooper Wire Angiodynamics, Inc. Brandon M. Brackett
K200671 06/19/2020 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for Ansell Healthcare Products LLC Donald Cronk
K201212 06/05/2020 Voyant Open Fusion Device Applied Medical Resources Corp. Sherif Nakhla
K200268 06/03/2020 HaloÖ Single-Loop Snare Kit Argon Medical Devices, Inc. Ana Jimenez-Hughes
K200068 06/29/2020 Arthrex DynaNite K-Wire Arthrex Inc. Rebecca R Homan
K200057 06/04/2020 bioli lOL Delivery System AST Products, Inc. William Lee
K192003 06/10/2020 Auxein Nailing System Auxein Medical Private Limited Rahul Luthra
K200855 06/24/2020 CINA AVICENNA.AI Cyril Di Grandi
K201313 06/15/2020 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) Aziyo Biologics, Inc. Wendy Perreault
K200528 06/02/2020 Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism Bausch + Lomb, Incorporated Barbara Klube-Falso
K201464 06/30/2020 Altapore MIS Baxter Healthcare Corporation Phillip Romei
K201288 06/12/2020 ExpanSure Large Access Transseptal Dilator Baylis Medical Company Inc. May Tsai
K201423 06/29/2020 MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ?g/mL) Beckman Coulter, Inc. Elaine Duncan
K201668 06/23/2020 VarseoSmile Crown plus BEGO Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KG Tanja Goetz
K193477 06/24/2020 Nd: YAG Laser Therapy Systems Beijing Kes Biology Technology Co., Ltd. Wei Meng Meng
K200042 06/09/2020 CO2 Laser System Beijing Superlaser Technology Co., Ltd. Shi Shuang
K200582 06/25/2020 Bendit2.7 Steerable Microcatheter Bend It Technologies Ltd. Simona Beilin-Nissan
K192033 06/09/2020 Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip Bennett Jacoby, DDS, MS, Inc. Bennett Jacoby
K192274 06/18/2020 BV Dental Implant System Bio Concept Co., Ltd Xiaodong Dai
K193632 06/30/2020 LassoStar Circular Mapping Catheter Biosense Webster, Inc. Michelle Wheeler
K193513 06/18/2020 SIGNAFUSE Bioactive Bone Graft Bioventus Kim Patterson Kelly
K201022 06/12/2020 REAL INTELLIGENCE CORI (CORI) Blue Belt Technologies, Inc. Corrine Herlinger
K193473 06/26/2020 LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US Boston Scientific Corporation Melissa Klamerus
K193307 06/02/2020 HIP7 Brainlab AG Cherita James
K200980 06/11/2020 Auto 3D Bladder Volume Tool Butterfly Network, Inc. Brian Sawin
K192549 06/22/2020 Byteflies Kit Byteflies NV Benjamin Vandendriessche
K200627 06/22/2020 GlidePath 10F Long-Term Dialysis Catheter C R Bard, Inc Joan Bergstrom
K193021 06/03/2020 Vantage Orian 1.5T, MRT-1550, V6.0 Canon Medical Systems Corporation Paul Biggins
K200883 06/04/2020 CarboClear« Cervical Plate System Carbofix Orthopedics Ltd. Yael Rubin
K201373 06/26/2020 DRX-Compass Carestream Health, Inc Duane Gutowski
K193376 06/15/2020 Visalis V500, Visalis S500 Carl Zeiss Meditec AG Katrin Faber
K200602 06/03/2020 Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant CC Wellness LLC Marlent Perez
K191276 06/30/2020 Dental Electrical Motor iRoot Pro ChangZhou BoMedent Medical Technology Co., Ltd. Chen YuLong
K200506 06/03/2020 DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader Chembio Diagnostic Systems Louise Muscat Sigismondi
K191461 06/05/2020 Exofin Fusion Skin Closure System Chemence Medical, Inc. Kenneth N Broadley
K200445 06/24/2020 The C100 Contactless Breathing Monitor Circadia Technologies Ltd. Michal Maslik
K201007 06/11/2020 In-Ka Ureteral Balloon Dilatation Catheter Coloplast Corp Cori Ragan
K192954 06/19/2020 Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Comfort Rubber Gloves Industries Sdn. Bhd. Ng Kok Howe
K201337 06/18/2020 InPen System Companion Medical, Inc. Jasper Benke
K201023 06/16/2020 iTotal« Identity Posterior Stabilized Knee Replacement System Conformis, Inc. Nancy Giezen
K200540 06/01/2020 BRAINSTREAM Disposable Deep Cup EEG Electrodes CONMED Corporation Tessa Hopsicker
K200663 06/24/2020 ControlRad Trace Model 9 ControlRad, Inc. Chris Fair
K200087 06/15/2020 F3D Cervical Stand-Alone Interbody Fusion System CoreLink, LLC Steven Mounts
K200888 06/27/2020 OMNIBotics Knee System Corin Ltd. Christina Rovaldi
K193042 06/26/2020 Optimized Positioning System (OPS) ReView Corin USA Lucinda Gerber
K193077 06/01/2020 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Covidien Stacy Barton
K201063 06/09/2020 DANNIK Disposable Monopolar Laparoscopic Instrument Dannik Olga Haberlad
K201247 06/10/2020 Intraoral Sensor Dentium Co., Ltd (ICT Branch) Sangwoo Lee
K201140 06/22/2020 Axeos Dentsply Sirona Karl J. Nittinger
K201347 06/18/2020 DePuy ATTUNEÖáTotal Knee System DePuy Orthopaedics, Inc. Karen Mahoney
K193540 06/16/2020 TRUMATCH Personalized Solutions DePuy Orthopaedics, Inc. Erin Combs
K200232 06/23/2020 LVivo Software Application DiA Imaging Analysis Ltd Michal Yaacobi
K200175 06/25/2020 DIA-ROOT BIO Sealer Diadent Group International Kab Sun Lee
K192337 06/22/2020 Zeroveno Dimedi Co., Ltd. Nam Youn
K200616 06/11/2020 E>EyeC E-SWIN Emeric OBIN
K193379 06/12/2020 Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe Edwards Lifesciences, LLC Wendy Vera Gonzalez
K200909 06/12/2020 Hemo Control (optional Add Pack Hemo Control DM) EKF-diagnostic GmbH Andrew J. Rutter
K200574 06/19/2020 EksoNR Ekso Bionics, Inc. Jack Peurach
K193226 06/03/2020 AltiVate Anatomic Canal-Sparing (CS) Shoulder Encore Medical, L.P Teffany Hutto
K193600 06/26/2020 EndoGI Biliary Stent System EndoGI Medical, Ltd. Omri Naveh
K200107 06/05/2020 epoc Blood Analysis System Epocal Inc. Amanda Barriage
K200420 06/29/2020 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
K193555 06/04/2020 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate Ever Global (Vietnam) Enterprise Corp Jerry Lin
K201430 06/20/2020 InFrameÖ Cannulated Fixation System ExsoMed, Corp. Jung Chang
K190637 06/19/2020 Fit & Brilliant Dental Implant System F&B Technology Co., Ltd. J H An
K200698 06/29/2020 Somnera System FRESCA Medical Inc. Mary Lou Mooney
K200481 06/18/2020 Andorate Biopsy Valve, Andorate Biopsy Irrigator GA Health Company Limited Cindy Ye
K200495 06/24/2020 Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve GA Health Company Limited Cindy Ye
K200998 06/11/2020 Versana Active GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K191923 06/20/2020 EverLift Submucosal Lifting Agent GI Supply Erika Parry
K201107 06/22/2020 Opera Lebody (Gold), Opera Lebody (Zafiro) GTG Wellness Co., Ltd. Sang Won Jun
K192201 06/12/2020 Electrical Stimulator System Gymmax Technology Shenzen Co., Ltd. Benson Wang
K200134 06/01/2020 Jimushi Sterile Urethral Catheter for single use Hangzhou Jimushi Meditech Co., Ltd. Fenlong Wu
K200897 06/01/2020 Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) Hartalega SDN. BHD. Kuan Kam Hon
K200521 06/12/2020 Full Automatic(NIBP) Blood Pressure Monitor Health & Life Co., Ltd Simon Lee
K192028 06/25/2020 Yumizen C1200 CRP Horiba ABX SAS Caroline Ferrer
K193525 06/26/2020 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M Horiba ABX SAS Caroline Ferrer
K200975 06/24/2020 Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum Huntleigh Healthcare Limited Steve Monks
K200825 06/26/2020 NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense Hycor Biomedical Irene M. Guzman
K200736 06/26/2020 Stardust Med I.T.S. Group S.R.L. Claudio Bellina
K200295 06/25/2020 IlluminOss Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K181813 06/09/2020 ImmersiveView Surgical Plan (IVSP«) ImmersiveTouch P. Pat Banerjee
K201311 06/18/2020 PF4 IgG assay Immucor GTI Diagnostics, Inc. Allison Stray
K192221 06/25/2020 Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts Implant Direct Sybron Manufacturing, LLC Reina Choi
K200265 06/30/2020 Surgical Drills Implant Direct Sybron Manufacturing, LLC Reina Choi
K200424 06/18/2020 Giotto Class (Models - 3000X-YY and 4000X-YY) IMS GIOTTO S.p.A. Antonella Rossi
K200753 06/09/2020 IBS Implant System II InnoBioSurg Co., Ltd. Bo-Yeon Lim
K200874 06/30/2020 TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End Innovasis, Inc. Marshall McCarty
K201507 06/29/2020 Cadence Total Ankle System Integra Lifesciences Corporation Cassidy Lemkau
K200774 06/23/2020 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation Alexandra Wells
K201146 06/26/2020 Ion Endoluminal System Intuitive Surgical, Inc. Jennifer Siu
K200760 06/26/2020 Rapid ASPECTS iSchemaView Inc. Jim Rosa
K182081 06/26/2020 JDentalCare Implant System JDIcon J Dental Care S.r.l. Giacomo Grandi
K193234 06/18/2020 NUVO IF Implant System JJGC Industria e Comercio de Materiais Dentarios S.A. Luiza Vaccari Toppel
K201096 06/23/2020 CO2mbiLED Karl Storz Endoscopy America, Inc. Winkie Wong
K192963 06/19/2020 Kogent Torus Ultrasonic Aspirator Katalyst Surgical, LLC Meryl Koch Wilhelm
K192778 06/30/2020 Kinos Axiom Total Ankle System Kinos Medical Brian Garvey
K193288 06/16/2020 Koya Ripple Koya, Inc. Andy Doraiswamy
K200756 06/12/2020 Kubtec Mozart Supra KUB Technologies, Inc. Chester Lowe
K200907 06/03/2020 Thales 3D Mr Scanner LAP GmbH Laser Applikationen Martin Pfabel
K200614 06/25/2020 FiteBac Antimicrobial Cavity Cleanser Largent Health, LLC Kirk Kimmerling
K201223 06/04/2020 LZI Tramadol Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K200277 06/04/2020 Livongo Blood Glucose Monitoring System (BG1000) Livongo Health, Inc. Jacob Gendler
K200875 06/17/2020 ArtiSential Laparoscopic Instruments - Electrodes LivsMed Inc. Dong Wook Lee
K200389 06/17/2020 INOmax DSIR Plus Mallinckrodt Manufacturing LLC David Trueblood
K192604 06/18/2020 Servo-air 4.0 Ventilator System Maquet Critica Care AB David Ardanius
K200834 06/25/2020 Lever Action Plate System McGinley Orthpaedic Innovations, LLC Adam M. Johnson
K200508 06/15/2020 Pump In Style Medela LLC PJ Pasia
K191443 06/26/2020 MSDI Dental Implants System Medical Systems and Devices International Ltd. Iman Khorshid
K201319 06/17/2020 Medline UNITE Jones Fracture Screw System Medline Industires, Inc. Jennifer Mason
K200356 06/11/2020 MEDO ARIA Medo.ai Dornoosh Zonoobi
K200949 06/04/2020 HEALIX ADVANCE Anchor with DYNATAPE Suture Medos International SARL Elizabeth Messana
K200514 06/03/2020 Cardioblate Gemini-s Surgical Ablation Device Medtronic Rahul Shah
K201327 06/18/2020 NavLock Trackers Medtronic Navigation Taylor Gold West
K201175 06/03/2020 StealthStation Cranial Software v1.3.0 Medtronic Navigation Inc. Amelia Striegel
K200723 06/26/2020 StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) Medtronic Navigation Inc. Carey Brenner
K191491 06/05/2020 EZ-Cover MedXPress.Pro Katherine Hughey
K200283 06/18/2020 Medussa-PL Cage Medyssey USA, Inc. Shawn Kim
K200250 06/26/2020 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
K193399 06/17/2020 Miru 1day UpSide (midafilcon A) Menicon Co., Ltd. Li Haosheng
K200967 06/06/2020 mCare(R) Powder Free Nitrile Orange Examination Gloves Mercator Medical (Thailand) LTD. Dariusz Jan Krezymon
K200297 06/18/2020 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K200685 06/11/2020 RIGEL 3DR Anterior Cervical Interbody Fusion System MiRus, LLC Jordan Bauman
K192542 06/16/2020 Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde Modern Medical Equipment Manufacturing, LTD. Jerry Cheung
K201414 06/25/2020 Rotium Bioresorbable Wick Nanofiber Solutions, LLC Jason Chakroff
K201117 06/11/2020 Gold Anchor Naslund Medical AB Tomas Naslund
K193094 06/10/2020 Naviswiss Hip Navigation System Naviswiss AG Jan Stifter
K201101 06/02/2020 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil NeoCoil, LLC Katie Gonzalez
K200441 06/05/2020 UroLift Advanced Tissue Control (ATC) System NeoTract, Inc. Brian Gall
K200840 06/26/2020 DuoHex CH Cannulated Hammertoe System Nextremity Solutions, Inc. Elise Fox
K200471 06/19/2020 Infrared Thermometer Model Number RN-60A,RN-60B Ningbo Ranor Medical Science & Technology Co., Ltd. Emma Hu
K192900 06/29/2020 H500 Multi-Sensing Oximetry System Nonin Medical, Inc. Kim E Aves
K200195 06/22/2020 NES Reprocessed Visions PV .014P RX Digital IVUS Catheter Northeast Scientific, Inc. Matthew Farley
K201151 06/22/2020 O-Mec 690 Series Laparoscopes OMEC Medical, Inc. Claire Nippress
K193620 06/18/2020 OptoMonitor 3 Opsens Inc. Marc Chaunet
K200815 06/25/2020 VitriGuard ORIGIO a/s Christine Kupchick
K200892 06/18/2020 Harvey(R) Surgical Assistant OrthAlign Inc Karyl Haskell
K201481 06/15/2020 Centurion POCT System Orthofix Inc. Jacki Koch
K200615 06/05/2020 Signature ONE System Orthosoft Inc. (d/b/a Zimmer CAS) Sankalp Dere
K201503 06/29/2020 Edge Air(1417) Digital Flat Panel X-ray Detector Osko, Inc. Richard Jeon
K192310 06/03/2020 Flap Fixator, Burr Hole Cover Ossaware Biotech Co., Ltd. Meng Feng Huang
K200684 06/02/2020 gastroduodenal FTRD Set Ovesco Endoscopy AG Marc O. Schurr
K192710 06/24/2020 The Simple Locking Intramedullary (Slim) System Pega Medical Inc. Ariel R. Dujovne
K201271 06/11/2020 Benchmark BMX96 Access System Penumbra, Inc. Matthew Benenati
K200911 06/02/2020 MIRA Adapter Phakos Olivier Aumaitre
K200974 06/03/2020 QLAB Advanced Quantification Software Philips Healthcare Travis Catania
K193415 06/11/2020 physIQ Heart Rhythm and Respiration Module physIQ, Inc George Allen Hides
K200095 06/26/2020 Streamline Navigated Instruments Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Kurtis Hunsberger
K201339 06/19/2020 The NOxBOXi Nitric Oxide Delivery System Praxair, Inc. Dave Loflin
K200952 06/05/2020 Hummingbird Tympanostomy Tube System Preceptis Medical, Inc Steve Anderson
K200131 06/10/2020 BruxZir Steel Prismatik Dentalcraft, Inc. So Hyun Park
K193438 06/02/2020 DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) Pro Med Instruments GmbH Muhammad Zubair
K193361 06/01/2020 ProCell Surgical Sponge-Blood Recovery Unit ProCell Surgical, Inc. Robert Krensky
K200459 06/03/2020 pREBOA-PRO Catheter Prytime Medical Devices, Inc. Brian Young
K201455 06/30/2020 Litho 150, Cyber Ho 150 Quanta System Spa Francesco Dell'Antonio
K200899 06/15/2020 Quantib AI Node Quantib BV Floor van Leeuwen
K200889 06/02/2020 iMac 27 & PL 4.0 Quantum-Spectra LLC Marc Leppla
K200438 06/19/2020 MPS 3 Myocardial Protection System Quest Medical, Inc. Tosan Onosode
K200921 06/17/2020 qER Qure.ai Technologies Pooja Rao
K201119 06/26/2020 ChartCheck Radformation, Inc. Kurt Sysock
K200104 06/04/2020 Oxylight RAJA Trading Company, Inc. Robert J Adipietro
K200487 06/10/2020 RayCare 3.1 RaySearch Laboratories AB (publ) Viktoria Hammarstedt
K192747 06/17/2020 Yxoss CBR« ReOss GmbH Michael Peetz
K192779 06/02/2020 Bunny Wax Personal Lubricant Reoxcyn, LLC Ellie Hartz
K200226 06/26/2020 RetroFix Retrofix Screws, LLC Keith A Barritt
K200617 06/23/2020 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 Richard Wolf Medical Instruments Corporation Michael Loiterman
K192910 06/19/2020 STATClave G4 Chamber Autoclave SciCan Ltd. Teresa Boyce
K200879 06/10/2020 SeaSpine Meridian System, SeaSpine Regatta Lateral System SeaSpine Orthopedics Corporation Aly Alvarez
K190408 06/16/2020 Spinal Fixation System Shangdong Kangsheng Medical Devices Co., Ltd. Wenxing Dong
K192601 06/01/2020 uWS-MR Shanghai United Imaging Healthcare Co., Ltd Xin Gao
K192630 06/11/2020 uWS-MI Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K200976 06/10/2020 SR-8230, SR-8230S Portable X-ray Unit Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) Flower Cai
K200727 06/18/2020 TENS and Muscle Stimulator Shenzhen As Tec Technology Co., Ltd Connie Li
K193253 06/17/2020 Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 Shenzhen Changkun Technology Co., Ltd. Steve Li
K192404 06/22/2020 Patient Monitoring Cable (SpO2 Extension Cable) Shenzhen Coreray Technology., Ltd Simon Fan
K193354 06/08/2020 Air Compression Therapy Device Shenzhen Dongjilian Electronics Co.,Ltd. Zhang Hong
K200354 06/29/2020 Electronic stimulator Shenzhen Dongjilian Electronics Co.,Ltd. Zhang Hong
K200437 06/25/2020 Blood Pressure Monitor Shenzhen Jamr Technology Co., Ltd. Luo Fusheng
K192466 06/22/2020 Air Compression Therapy System Shenzhen Lifotronic Technology Co., Ltd. Xiang Lei
K200015 06/08/2020 ePM Series Patient monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yanhong Bai
K193348 06/25/2020 Blood Pressure Monitor Shenzhen Viatom Technology Co., Ltd. Zhou Saixin
K201156 06/29/2020 ARTIS pheno (VE2) Siemens Medical Solution USA, Inc. Patricia D. Jones
K201462 06/24/2020 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Sulgue Choi
K193290 06/17/2020 AI-Rad Companion Brain MR Siemens Medical Solutions USA, Inc. Lauren Bentley
K193166 06/12/2020 MAMMOMAT Revelation Siemens Medical Solutions USA, Inc. Martin Rajchel
K201202 06/02/2020 MI View&GO Siemens Medical Solutions USA, Inc. Clayton Ginn
K192024 06/19/2020 Cemented TSI Hip Stem Signature Orthopaedics Pty Ltd. Declan Brazil
K193075 06/09/2020 Osteo3 ZP Putty Sirakoss Ltd. Jordan Conway
K200538 06/01/2020 Skeletal Dynamics Forearm Plating System Skeletal Dynamics, Inc. Diana Taylor
K200227 06/04/2020 Journey II XR Knee Instrument Smith & Nephew, Inc Meenakshi Gupta
K193003 06/05/2020 NemoCast Software Nemotec S.L. Carlos Arias
K201029 06/17/2020 Sapphire« Spinal System, Sapphire X Anterior Cervical Plate Spinal System Spinal Elements, Inc. Julie Lamothe
K193106 06/19/2020 SpineFrontier Lumbar Interbody Fusion Device System SpineFrontier, Inc. Vito Lore
K192952 06/05/2020 Spire Health Remote Patient Monitoring System Spire, Inc. d/b/a Spire Health Joanne Hollenbach
K193577 06/01/2020 SleepRight ProRx Custom Dental Guard Splintek, Inc. Thomas W Brown
K201370 06/19/2020 Multiflex Tinnitus Technology Starkey Laboratories, Inc. Ka Zoua Xiong
K200446 06/13/2020 STERIS Patient Warming System STERIS Corporation Gregory Land
K200398 06/05/2020 AxSOS 3 AF System and AxSOS 3 Ti System Stryker GmbH Paul Nelson
K200467 06/16/2020 Control-IQ Technology Tandem Diabetes Care, Inc. Michael Sarrasin
K201214 06/04/2020 t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. Ashley Reynolds
K200272 06/30/2020 Terragene Chemdye Terragene SA Maria Victoria Rocha
K201255 06/10/2020 TSolution« One Total Knee Application THINK Surgical, Inc. Meliha Mulalic
K193150 06/05/2020 Latex Examination Powder Free Glove, Aloe Vera Top Glove SDN BHD Noor Akilah BT Saidin
K191913 06/19/2020 TruAbutment DS TruAbutment Inc. Kiyoon Nam
K200772 06/23/2020 ULab Systems uDesign Software ULab Systems, Inc. Charlie Wen
K200720 06/26/2020 D-Stat Radial Topical Hemostat Vascular Solutions LLC Iroquois Ledbeter
K193119 06/29/2020 Twin-Pass Dual Access Catheter Vascular Solutions LLC Iroquois Ledbeter
K193319 06/01/2020 XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System Vasoptic Medical Inc. Abhishek Rege
K200786 06/09/2020 Venus Epileve Venus Concept USA Inc. Yoni Iger
K201164 06/26/2020 Venus Viva MD Device Venus Concept USA Inc. Yoni Iger
K191620 06/01/2020 Vitls Platform Vitls Inc. Werner Vorster
K192957 06/05/2020 VivaChek Blood Glucose and B-Ketone Monitoring System Vivachek Biotech (Hangzhou) Co., Ltd Mark Qian
K201340 06/19/2020 AQUILA 320 D / AQUILA 320 S VMI Tecnologias LTDA Siele Santos
K201322 06/17/2020 Entuit Nasal Jejunal Feeding Tube Wilson-Cook Medical, Inc Tiffanny A Thomas
K200972 06/10/2020 Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc Marge Walls-Walker
K193067 06/08/2020 The INBONEÖ Total Ankle System, the INFINITYÖ Total Ankle System and the INVISIONÖ Total Ankle Revision System Wright Medical Technology, Inc. Antonio Ayala
K200929 06/03/2020 Hair Growth System Xuzhou Kernel Medical Equipment Co., Ltd. Wang Jing
K192478 06/17/2020 LT Antibacterial Alginate with Silver Dressing Zhejiang Longterm Medical Technology Co., Ltd. Claudia Zsang


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact