FDA 510(k) Applications Received During March, 2020

FDA 510(k) Number Submission Date Device Name Applicant Contact
K200766 03/25/2020 3M Attest Steam Chemical Integrator Test Pack 3M Company Mary Fretland
K200835 03/31/2020 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad 3M Company Hilary B. Hovde
K200536 03/03/2020 3MTM AttestTM Rapid 5 Steam-Plus Test Pack 3M Complany Mary Fretland
K200712 03/18/2020 Rumble Tuff Electric Breast Pump A Cute Baby, Inc. Matthew Kho
K200721 03/19/2020 Agilis HisPro Steerable Catheter With Electrodes Abbott (St. Jude Medical) Winnie Yik
K200566 03/04/2020 ADAPT Tissue Admedus Regen Pty Ltd Kiran Bhirangi
K200659 03/12/2020 Dermalux Tri-Wave MD Aesthetic Technology Ltd. Dale Needham
K200532 03/02/2020 StarPore Anatomics Pty, Ltd. Christine Scifert
K200531 03/02/2020 iHealth Infrared No-Touch Forehead Thermometer Andon Health Co., Ltd. Liu Yi
K200671 03/13/2020 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for Ansell Healthcare Products LLC Donald Cronk
K200598 03/09/2020 Voyant Maryland Fusion Device Applied Medical Resources Corp. Blake Stacy
K200634 03/10/2020 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Arrow International Inc. Apurva N. Gokhale
K200674 03/16/2020 AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector Atrility Medical, LLC Matthew Knoespel
K200641 03/11/2020 HaloGUARD Protective Disc with CHG ATTWILL Medical Solutions Attilio Di Fiore
K200855 03/31/2020 CINA AVICENNA.AI Cyril Di Grandi
K200568 03/04/2020 B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System B & J Manufacturing Ltd Billy Yu
K200528 03/02/2020 Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism Bausch + Lomb, Incorporated Barbara Klube-Falso
K200640 03/11/2020 ALTAPORE SHAPE Baxter Healthcare Corporation Phillip Romei
K200582 03/06/2020 Bendit2.7 Steerable Microcatheter Bend It Technologies Ltd. Simona Beilin-Nissan
K200533 03/02/2020 binx io CT/NG Assay and binx io CT/NG System binx health Inc Sarah Kalil
K200512 03/02/2020 ETEST Plazomicin (PLZ) (0.016-256 ?g/mL) bioM?rieux S.A. Alexia Bosquet
K200590 03/06/2020 VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 ?g/mL) bioMerieux, Inc Cherece L. Jones
K200787 03/26/2020 BSD3543W Bontech Co. Ltd Ki Chan Ahn
K200733 03/20/2020 Opticross 35 15 MHz Peripheral Imaging Catheter Boston Scientific Corporation Jennifer L. Foley
K200822 03/30/2020 Braid Braid.Health Vivian Liu
K200627 03/10/2020 GlidePath 10F Long-Term Dialysis Catheter C R Bard, Inc Joan Bergstrom
K200600 03/09/2020 Sentinel C-Rad Positioning AB Thomas Matzen
K200818 03/30/2020 3DMax MID Anatomical Mesh C.R. Bard, Inc. Shannon Green
K200755 03/23/2020 Caption Guidance Caption Health Sam Surette
K200621 03/09/2020 Caption Interpretation Automated Ejection Fraction Software Caption Health Sam Surette
K200519 03/02/2020 CarboClear« II Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K200824 03/30/2020 Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown Cardinal Health 200, LLC Caroline Miceli
K200584 03/06/2020 xPORT 304 (miCOR) System Lens Fragmentation System Carl Zeiss Meditec Cataract Technology Inc Gary Mocnik
K200602 03/09/2020 Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant CC Wellness LLC Marlent Perez
K200688 03/16/2020 hyperion X5, NewTom GO, X-RADiUS COMPACT CEFLA S.C. Lorenzo Bortolotti
K200506 03/02/2020 DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader Chembio Diagnostic Systems Louise Muscat Sigismondi
K200780 03/25/2020 XBit Series Digital Color Doppler Ultrasound System CHISON Medical Technologies Co., Ltd. Qifei Liu
K200576 03/05/2020 ClearMask Transparent Surgical Face Mask ClearMask, LLC Aaron Hsu
K200540 03/03/2020 BRAINSTREAM Disposable Deep Cup EEG Electrodes CONMED Corporation Tessa Hopsicker
K200629 03/10/2020 Aspire Mechanical Aspirator G Control Medical Technology Shawn Fojtik
K200663 03/13/2020 ControlRad Trace Model 9 ControlRad, Inc. Chris Fair
K200714 03/18/2020 AVIEW Coreline Soft Co., Ltd Hyeyi Park
K200796 03/26/2020 Emprint Ablation System with Thermosphere Technology Covidien LLC Liron Bar yaakov
K200700 03/17/2020 Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter Creagh Medical Ltd. Amy Yanta
K200705 03/18/2020 Nurochek System Cryptych Pty Ltd Angela Roche
K200552 03/03/2020 EVOS Lumbar Interbody System Cutting Edge Spine, LLC Kyle Kuntz
K200854 03/31/2020 DePuy PINNACLE Dual Mobility Liner DePuy Ireland UC Erin Combs
K200809 03/27/2020 D-LUX+ Diadent Group International Kab Sun Lee
K200752 03/23/2020 DB-Orthopedics Dimensional Bioceramics, LLC Duran N. Yetkinler
K200654 03/12/2020 Rubicon SA System Dymedix Diagnostics, Inc. Jim Moore
K200616 03/09/2020 E>EyeC E-SWIN Emeric OBIN
K200655 03/12/2020 FibroScan« 630 Echosens Karine Bonenfant
K200776 03/25/2020 Eko CORE Eko Devices, Inc. Arezou Azar
K200648 03/12/2020 EKOS PE Endovascular Device with Control System 4.0 (CS4.0) EKOS Corporation Joshua Kim
K200574 03/05/2020 EksoNR Ekso Bionics, Inc. Jack Peurach
K200523 03/02/2020 Biolign« Roto-Loc Cervical Plate System Elite Surgical Supplies (PTY) LTD Thanos Spirakis
K200624 03/10/2020 Percutaneous Introducer Epimed International Inc. Preston Frasier
K200841 03/31/2020 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 Ethicon Endo-Surgery, Llc Nathan Anderson
K200667 03/13/2020 EyeArt Eyenuk, Inc Kaushal Solanki
K200803 03/27/2020 BEAR and BEAR mini FOREO, Inc. Laura HoShue
K200698 03/17/2020 Somnera System FRESCA Medical Inc. Mary Lou Mooney
K200530 03/02/2020 AMICUS Separator System Fresenius Kabi AG Kim Forch
K200668 03/13/2020 DR-ID 1200SDK System FUJIFILM Corporation Randy Vader
K200850 03/31/2020 Fujifilm Ultrasonic Processor FUJIFILM Corporation Randy Vader
K200775 03/25/2020 LOOP LED Curing Light System Garrison Dental Solutions, LLC Alex Hull
K200743 03/23/2020 Vivid E80/ Vivid E90/ Vivid E95 GE Medical Systems Ultrasound and Tracey Ortiz
K200708 03/18/2020 Vivid iq GE Medical Systems Ultrasound and Tracey Ortiz
K200852 03/31/2020 EchoPAC Software Only, EchoPAC Plug-In GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K200851 03/31/2020 Vivid T8, Vivid T9 GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K200592 03/06/2020 GS Medical AnyPlus PEEK Cage System GS Medical Co., Ltd. Andrea Watt
K200581 03/05/2020 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega NGC SDN. BHD. Kuan Mun Leong
K200541 03/03/2020 HiveÖ Stand-alone Anterior Lumbar Interbody System HD LifeSciences LLC John Sullivan
K200521 03/02/2020 Full Automatic(NIBP) Blood Pressure Monitor Health & Life Co., Ltd Simon Lee
K200782 03/26/2020 Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite Howmedica Osteonics Corp. Nora O'Connor
K200556 03/03/2020 AquaFlate Pre-Filled Sterile Water Syringe 10mL HR Pharmaceuticals, Inc. Colby Wiesman
K200846 03/31/2020 BalteumÖ Lumbar Plate System Huvexel Co., Ltd Sung Kyu Hur
K200825 03/30/2020 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
K200729 03/20/2020 HydroCision SpineJet System HydroCision, Inc. Mark J Lewis
K200736 03/23/2020 Stardust Med I.T.S. Group S.R.L. Claudio Bellina
K200801 03/27/2020 Quantisal Oral Fluid Collection Device Immunalysis Corporation Wenying (Jessica) Zhu
K200762 03/24/2020 CoLink Cfx Plating System In2Bones USA, LLC Christine Scifert
K200753 03/23/2020 IBS Implant System II InnoBioSurg Co., Ltd. Bo-Yeon Lim
K200564 03/04/2020 Aria System Inova Labs Reuben Lawson
K200586 03/06/2020 Straumann TLX Implant System Institut Straumann AG Renate Reiss
K200744 03/23/2020 Instylla Microcatheter Instylla, Inc. Jennifer Greer
K200774 03/25/2020 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation Alexandra Wells
K200529 03/02/2020 Orion interacoustics A/S Erik Nielsen
K200534 03/02/2020 VisualEyes Interacoustics A/S Erik Nielson
K200503 03/02/2020 ATL Anchors International Life Sciences Tiffini Wittwer
K200622 03/09/2020 Focus 43C detector, TRIMAX 43C detector iRay Technology Taicang Ltd. Meng Li
K200807 03/27/2020 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit IRRAS USA Inc. Niloufa Insanally
K200760 03/24/2020 Rapid ASPECTS iSchemaView Inc. Jim Rosa
K200827 03/30/2020 LOCATOR R-Tx Ivory Super Holdco, Incp. Marysa Loustalot
K200763 03/24/2020 Osteo-site Vertebral Balloon IZI Medical Qiang Cao
K200561 03/04/2020 StimPlus Patch, StimPlus Patch, StimPlus Patch JKH Health Co., LTD Pu Jiang
K200649 03/12/2020 Arm-Type Fully Automatic Digital Blood Pressure Monitor Joytech Healthcare Co., Ltd Ren Yunhua
K200599 03/09/2020 Digital Thermometer Joytech Healthcare Co., Ltd Ren Yunhua
K200740 03/23/2020 HD Video Rhino Laryngoscope KARL STORZ Endoscopy - America, Inc. Irina Fedorov
K200756 03/24/2020 Kubtec Mozart Supra KUB Technologies, Inc. Chester Lowe
K200709 03/18/2020 Kyocera Bipolar Hip System Kyocera Medical Technologies, Inc. Anthony DeBenedictis
K200614 03/09/2020 FiteBac Antimicrobial Cavity Cleanser Largent Health, LLC Kirk Kimmerling
K200690 03/16/2020 LifeSignals ECG Remote Monitoring Patch Platform LifeSignals, Inc. Saravanan Balasubramanian
K200653 03/12/2020 AMF Revision TT Cones LimaCorporate S.p.A Roberto Gabetta
K200656 03/12/2020 Delta Multihole TT Pro Acetabular System Limacorporate S.P.A. Michela Zanotto
K200670 03/13/2020 EON Portable RO Water Purification System Mar Cor Purification, Inc. Mark Arnold
K200834 03/30/2020 Lever Action Plate System McGinley Orthpaedic Innovations, LLC Adam M. Johnson
K200548 03/03/2020 CUBEScan BioCon-1100 Mcube Technology Co., Ltd. Hye-Ri Choi
K200749 03/23/2020 CUBEScan BioCon-900S Mcube Technology Co., Ltd. Hye-Ri Choi
K200504 03/02/2020 BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote MED-EL Elektromedizinische Geraete GmbH Carolin Ralser
K200508 03/02/2020 Pump In Style Medela LLC PJ Pasia
K200791 03/26/2020 Navigation Enabled Intruments Medos International, SARL Daria Bochenek
K200511 03/02/2020 ROSA ONE Brain application Medtech S.A. Serge Tabet
K200514 03/02/2020 Cardioblate Gemini-s Surgical Ablation Device Medtronic Rahul Shah
K200723 03/19/2020 StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) Medtronic Navigation Inc. Carey Brenner
K200795 03/26/2020 LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit Medtronic, Inc. Eric Kalmes
K200630 03/10/2020 Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags Medtronic, Inc. Jen Correa
K200847 03/31/2020 Surgical Face Mask Mexpo International Inc. Tim Thai
K200738 03/23/2020 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K200848 03/31/2020 Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit Micron Medical Corporation Elizabeth Greene
K200547 03/03/2020 Traxcess 14 SELECT Guidewire MicroVention Inc. Ganesh Balachandar
K200685 03/16/2020 RIGEL 3DR Anterior Cervical Interbody Fusion System MiRus, LLC Jordan Bauman
K200742 03/23/2020 JUSHA-CP610 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K200805 03/27/2020 Neocis Guidance System (NGS) with Patient Splints Neocis Inc. Thomas E. Claiborne
K200840 03/31/2020 DuoHex CH Cannulated Hammertoe System Nextremity Solutions, Inc. Elise Fox
K200785 03/26/2020 StratumÖ Reduced Size Foot Plating System Nextremity Solutions, Inc. Adam Finley
K200543 03/03/2020 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System Nexxt Spine LLC Andy Elsbury
K200578 03/05/2020 Infrared Thermometer Model Number RN-50A,RN-50B Ningbo Ranor Medical Science & Technology Co., Ltd. Emma Hu
K200737 03/23/2020 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K200522 03/02/2020 AERO CHROME* Breathable Performance Surgical Gowns O&M Halyard, Inc Kimberly Lewis
K200546 03/03/2020 ZeeroMED View O3 Enterprise SRL Andrea Poli
K200542 03/03/2020 Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head Olympus Medical Systems Corp. Toshiyuki Nakajima
K200516 03/02/2020 OCT-Camera ID 21101A3 OptoMedical Technologies GmbH Julia Behrens
K200594 03/06/2020 Capnostream 35 Portable Respiratory Monitor Oridion Medical 1987 Ltd. Lital David
K200815 03/30/2020 VitriGuard ORIGIO a/s Christine Kupchick
K200680 03/16/2020 Synvitro Hyadase Origio a/s, a CooperSurgical Company Monika Bak
K200642 03/11/2020 OrthAlign Plus System OrthAlign, Inc. Karyl Haskell
K200696 03/17/2020 FIREBIRD SI Fusion System Orthofix Inc. Jacki Koch
K200606 03/09/2020 O-Genesis Graft Delivery System Orthofix, Inc. Troy Brooks
K200587 03/06/2020 VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder OrthoSensor, Inc. Deborah Escobar Johnson
K200665 03/13/2020 VERASENSE for Stryker Triathlon OrthoSensor, Inc. Deborah Escobar Johnson
K200615 03/09/2020 Signature ONE System Orthosoft Inc. (d/b/a Zimmer CAS) Sankalp Dere
K200741 03/23/2020 Tablo Hemodialysis System Outset Medical, Inc. Jennifer Mascioli-Tudor
K200684 03/16/2020 gastroduodenal FTRD Set Ovesco Endoscopy AG Marc O. Schurr
K200559 03/03/2020 CarpX PAVmed, Inc. Lishan Aklog
K200678 03/16/2020 PENTAX Medical Video Bronchoscope EB-J10 Series PENTAX of America, Inc. William Goeller
K200771 03/25/2020 Indigo Aspiration System Lightning Aspiration Tubing Penumbra, Inc. Micaela Victoria
K200812 03/27/2020 VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter Philips Image Guided Therapy Corporation Rand Daoud
K200713 03/18/2020 EchoNavigator Philips Medical Systems Nederland B.V. Ioana Ulea
K200603 03/09/2020 AAA Model Philips Ultrasound, Inc Hebe Sun
K200513 03/02/2020 DAC Dynamic Active Compression Plate Pioneer Surgical Technology, Inc., DBA RTI Surgical Linda Busklein
K200726 03/20/2020 AcuityPDR Radmedix LLC Gabriel Issa
K200652 03/12/2020 Lollipop BiteBlock RadTec Medical Devices, Inc. Ross Holman
K200849 03/31/2020 Tempus LS - Manual Remote Diagnostic Technologies, Ltd, a Philips Company Martin Newman
K200617 03/09/2020 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 Richard Wolf Medical Instruments Corporation Michael Loiterman
DEN200015 03/02/2020 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. Rita Hoady
K200518 03/02/2020 Pitkar External Fixation System - Rail Mechanism S H Pitkar Orthotools Pvt Ltd Vivek Mangalwedhekar
K200832 03/30/2020 Safey Peak Flow Meter Safey Medical Devices Pvt Ltd Taher Ali Moiyed
K200699 03/17/2020 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K200638 03/10/2020 LAP-iX Suction Irrigation Sejong Medical Co., Ltd. Yoojung Choi
K200751 03/23/2020 Photodynamic Therapy (PDT) Equipment Shangdong Huamei Technology Co., Ltd. Xu QingHua
K200746 03/23/2020 IPL Treatment Systems Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K200637 03/10/2020 SR-8100 Portable X-ray Unit Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) Flower Cai
K200727 03/20/2020 TENS and Muscle Stimulator Shenzhen As Tec Technology Co., Ltd Connie Li
K200643 03/11/2020 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous Shenzhen Mindray Bio-Medical Electronics Co., LTD Jiang Xiaoyong
K200836 03/31/2020 8ch Flex Suite Shenzhen RF Tech Co., Ltd. Gary Wang
K200509 03/02/2020 ADVIA Centaur Vitamin D Total (VitD) Siemens Healthcare Diagnostics Inc. Paul DaSilva
K200644 03/11/2020 ACUSON Freestyle Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Shruti Arora
K200707 03/18/2020 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Sulgue Choi
K200524 03/02/2020 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO Siemens Medical Solutions USA, Inc. Tabitha Estes
K200585 03/06/2020 Acuson SC2000 Diagnostic Ultrasound System Siemens Medical Solutions, USA, Inc. Christine Dunbar
K200515 03/02/2020 syngo.CT Cardiac Planning Siemens Medical Soultions USA, Inc. Veronica Padharia
K200538 03/03/2020 Skeletal Dynamics Forearm Plating System Skeletal Dynamics, Inc. Diana Taylor
K200701 03/18/2020 Skeletal Dynamics Midshaft Humerus Plating System Skeletal Dynamics, Inc. Diana Taylor
K200826 03/30/2020 Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks Smith&Nephew, Inc. Brad Sheals
K200571 03/04/2020 PERLA« Posterior Occipito-Cervico-Thoracic Fixation System SPINEART Franck Pennesi
K200816 03/30/2020 SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices SpineEX, Inc. Andrew Rogers
K200539 03/03/2020 Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl Sri Trang Gloves (Thailand) Public Company Limited Jarinya Jirojkul
K200517 03/02/2020 Standard Trocar Standard Bariatrics Alison Sathe
K200577 03/05/2020 RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector STERIS Corporation Jennifer Nalepka
K200597 03/09/2020 Straumann BLX Gold Abutments Straumann USA, LLC (On behalf of Institut Straumann AG) Chanrasmey White
K200613 03/09/2020 Tritanium« X TL Expandable Curved Posterior Lumbar Cage Stryker Corporation Jamie Wilson
K200666 03/13/2020 Stryker Xia 3 Power Adaptor Stryker Spine Megan Callanan
K200724 03/19/2020 VICTUS Femtosecond Laser Platform Technolas Perfect Vision GmbH Friedrich Moritz
K200747 03/23/2020 PuriLens Plus Preservative Free Saline The LifeStyle Company, Inc. Tom Seidner
K200632 03/10/2020 TCAT TKA Instrument Tray Set THINK Surgical, Inc. George J. Prendergast
K200625 03/10/2020 I-View Gold and Imagen Gold Dental Sensors Trident s.r.l Giorgio Rizzo
K200537 03/03/2020 Oxxiom True Wearables, Inc. Marcelo Lamego
K200838 03/31/2020 Tyece OTC TENS Model Tyece Limited Parshid Falahati
K200772 03/25/2020 ULab Systems uDesign Software ULab Systems, Inc. Charlie Wen
K200845 03/31/2020 Navigation Module of the Momentum System ulrich medical USA Hans Stover
K200745 03/23/2020 Lariat, Hot/Cold Snare United States Endoscopy Group, Inc. Carroll Martin
K200608 03/09/2020 Eclipse Treatment Planning System v16.0 Varian Medical Systems, Inc. Peter J. Coronado
K200720 03/19/2020 D-Stat Radial Topical Hemostat Vascular Solutions LLC Iroquois Ledbeter
K200786 03/26/2020 Venus Epileve Venus Concept USA Inc. Yoni Iger
K200703 03/18/2020 JiveX Visus Health IT GmbH Axel Schreiber
K200550 03/03/2020 Vitalograph Model 2120 In2itive eDiary Vitalograph Ireland Ltd. Tony O'Hanlon
K200833 03/30/2020 RX-1 Rhythm Express Remote Cardiac Monitoring System VivaQuant Inc. Brian Brockway
K200525 03/02/2020 Medical Diode Laser Hair Removal System Weifang Mingliang Electronics CO., LTD Li MingLiang
K200662 03/13/2020 X-Guide« Surgical Navigation System X-Nav Technologies,LLC. Fred Cowdery
K200695 03/17/2020 MATRx plus Zephyr Sleep Technologies Sabina Bruehlmann
K200814 03/30/2020 Affixus(R) Natural Nail(R) System Humeral Nail Zimmer GmbH Annemie Rehor Kausch
K200823 03/30/2020 Zimmer, Inc. Hip Joint Prostheses MR Labeling I Zimmer, Inc. Caleb Barylski
K200676 03/16/2020 ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA Zirkonzahn srl Julian Steger


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