FDA 510(k) Applications Received During July, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K191774 07/02/2019 SmileAlign Orthodontic Aligner System 3D Global Biotech Inc. Keng-Liang Ou
K191911 07/17/2019 3Shape Splint Design 3Shape A/S Shreyosi Chakraborty
K191771 07/02/2019 SECURE Screw A.M. Surgical, Inc. Vincent Pascale
K192037 07/30/2019 Advisor VL Circular Mapping Catheter, Sensor Enabled Abbott Medical Tamara L. Stanczak
K192019 07/29/2019 Dragonfly OpStarÖ Imaging Catheter, AptiVueÖ Software version E.5.1 Abbott Medical Richard DeMello
K191912 07/17/2019 BiWaze Cough ABMRC LLC Chad M Boerst
K191817 07/05/2019 ActivOrtho Continuous Compression Screw System ActivOrtho, Inc. Paul Hindrichs
K191812 07/05/2019 ADI Cervical Interbody Fusion Device Additive Device, Inc. (ADI) d/b/a restor3d Nathan Evans
K191847 07/10/2019 Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps Adeor Medical AG Florian Gehrmann
K192025 07/29/2019 STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader Advanced Sterilization Products (ASP) Elsie Kim
K191884 07/15/2019 DR 100s Agfa N.V. Wim Govaerts
K192032 07/30/2019 Fixone Biocomposite Small Anchor AJU Pharm Co., Ltd. Lee Gun Tak
K192016 07/29/2019 SMOOV O10 Alber GmbH Michael Vent
K191795 07/03/2019 AOCup Lens Case with AODisc Alcon Laboratories, Inc. Katryna Warren
K191807 07/05/2019 ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device ALPCO Jeffrey Freedman
K191836 07/09/2019 Ceramill A-Splint Amann Girrbach AG Debora Engel
K191843 07/09/2019 Ceramill A-Temp Amann Girrbach AG Debora Engel
K192048 07/31/2019 Single Use Endoscope Valves Set Anrei Medical (Hangzhou) Co., Ltd. Yang HuiBing
K191866 07/12/2019 GelPOINT Mini Advanced Access Platform Applied Medical Frans VandenBroek
K191758 07/01/2019 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit Argon Medical Devices, Inc. Jo Huang
K191960 07/23/2019 Arthrex Univers Revers Modular Glenoid System Arthrex Inc. Ivette Galmez
K192027 07/29/2019 WEREWOLF COBLATION System, COBLATION HALO Wand Arthrocare Corporation Shruthi Bhat
K192006 07/29/2019 SIRION Lateral Lumbar Interbody System Astura Medical, LLC Parker Kelch
K191989 07/25/2019 WVSM (Wireless Vital Signs Monitor) RWC + miniCap Athena GTX Sean Mahoney
K192003 07/26/2019 Auxein Nailing System Auxein Medical Private Limited Rahul Luthra
K191910 07/17/2019 SpaceStation MRI B. Braun Melsugen AG Ullrich Trottier
K191845 07/10/2019 Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) Barco NV Julie Vandecandelaere
K192005 07/29/2019 Bausch + Lomb PreVue Inserter for enVista Preloaded Bausch & Lomb, Inc Rekha Janarthanan
K191826 07/08/2019 KeYi Total Hip System Beijing KeYi Medical Device Technology Co., Ltd. Jenny Jiang
K191970 07/24/2019 Diode Laser Hair Removal System Beijing Sano Laser S&T Development Co., Ltd Hongbo Zhang
K191896 07/15/2019 Belimed Steam Sterilizer MST-H TOP 5000 Belimed AG Marc Luthi
K192033 07/30/2019 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
K192035 07/30/2019 EvaQMax Smoke Evacuation System Bio Protech, Inc. Namhyun Cho
K192050 07/31/2019 ETEST Eravacycline (ERV) (0.002 û 32 ?g/mL) bioMerieux SA Marine Taravant
K191953 07/22/2019 ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) BioMerieux SA Marine Taravant
K191766 07/01/2019 VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4?g/mL) bioMerieux, Inc. Esther Hernandez
K192007 07/29/2019 TheraBase, TheraBase Ca Bisco, Inc. Diana Vu
K191996 07/26/2019 BC Reflex Uni Knee System Bodycad Laboratories, Inc. Guy Sevigny
K191871 07/12/2019 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set Boston Scientific Corporation Kripa Pandya
K192043 07/31/2019 AXIOS Stent and Electrocautery Enhanced Delivery System Boston Scientific Corporation Kayla Mackey
K191789 07/03/2019 Stonetome Stone Removal Device Boston Scientific Corporation Laura Kuroski
K191966 07/23/2019 NewPrim System BRM Extremities Andrea De Maglio
K192012 07/29/2019 Capillus 112, Capillus 244 Capillus Patricia Schnoor
K191797 07/03/2019 BiomarC Fiducial Marker Carbon Medical Technologies Eric Furlich
K191879 07/15/2019 DRX-Evolution with Carestream Digital Tomosynthesis Carestream Health, Inc. Duane Gutowski
K191811 07/05/2019 Catalyst OrthoScience CSR Shoulder System Catalyst OrthoScience, Inc. Dale Davison
K191823 07/08/2019 Clear-Aligners CDB Corporation Leah M. Lehman
K191921 07/18/2019 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments Cochlear Americas Chinda Hemmavanh
K191876 07/15/2019 PulmoScan Cognita Labs, LLC Rajoshi Biswas
K191785 07/03/2019 Orion LifeSpan MEG Compumedics Limited William Alam
K191763 07/01/2019 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC CooperVision, Inc. Marie Dutton
K192040 07/31/2019 AVIEW Modeler Coreline Soft Co., Ltd Hyeyi Park
K191831 07/09/2019 MobiliT Cup Corin USA Limited Severine Siracusa
K192038 07/30/2019 Emprint Visualization Application Covidien LLC. Janna Babson
K191967 07/23/2019 Unyvero LRT BAL Application Curetis GmbH Karsten Mueller
K191810 07/05/2019 Curiteva Pedicle Screw System Curiteva, Inc. Eric Linder
K192010 07/29/2019 SmoothSkin BARE+ CyDen Limited Adam Stephens
K192000 07/26/2019 D R Burton OxyPAP D R Burton Healthcare, LLC Dennis Cook
K191786 07/03/2019 CyclopsÖ Anterior Cervical Plate System DeGen Medical INC Craig Black
K191806 07/05/2019 Propex IQ Apex Locator Dentsply Sirona Karl Nittinger
K191865 07/12/2019 SmartLite Pro Modular LED Curing Light Dentsply Sirona Karl Nittinger
K191779 07/02/2019 Attune Revision LPS Inserts Depuy (Ireland) Kathy Harris
K191833 07/09/2019 Dexcom G6 Pro Continuous Glucose Monitoring System Dexcom, Inc. Jacob Nardone
K192022 07/29/2019 DiaTemp Flow Diadent Group International Kab Sun Lee
K192046 07/31/2019 LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set DiaSorin Inc. John C. Walter
K191944 07/22/2019 MU2net DOSIsoft Marc Usynski
K191937 07/19/2019 Ezvena IPC, Ezvena SQS Eezcare Medical Corp Michelle C Mitchell
K192004 07/26/2019 Eko Analysis Software Eko Devices Inc Connor Landgraf
K191830 07/09/2019 gammaCore Sapphire Electrocore, Inc. Mike Romaniw
K191890 07/15/2019 Elos Accurate Customized Abutment Elos Medtech Pinol A/S Tina Friis Poulsen
K191919 07/18/2019 Elos Accurate Hybrid Base Elos Medtech Pinol A/S Tina Friis Poulsen
K192009 07/29/2019 LED Curing Light EZGO Group Inc. Hong Chen
K191997 07/26/2019 FAICO CMF System FAICO Medical LLC Heman Dario Fernandez
K192015 07/29/2019 Faico Dental Implant System FAICO Medical LLC Hernan Dario Fernandez
K191844 07/09/2019 Fidmi Low Profile Enteral Feeding Device Fidmi Medical Ltd Shahar Millis
K191818 07/05/2019 F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) Fisher & Paykel Healthcare Ltd Reena Daken
K191909 07/17/2019 HepaShield Bacterial Viral Breathing System Filter Flexicare Medical Limited Joel Biddle
K191987 07/25/2019 Orapeutic Forward Science Brian Pikkula
K192017 07/29/2019 Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K191747 07/01/2019 FUJIFILM Duodenoscope Model ED-580XT FUJIFILM Corporation Randy Vader
K191973 07/24/2019 Lumpipulse G CA19-9-N Fujirebio Dianostics, Inc. Kristin Maddaloni
K192041 07/31/2019 G21 SpaceFlex Hip G21 S.r.l Filippo Foroni
K192026 07/29/2019 Peridot Intervertebral body fusion System GBS Commonwealth Co., Ltd. Jimmy Kim
K191798 07/03/2019 Versana Active GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K191792 07/03/2019 Versana Balance GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K191777 07/02/2019 Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition GE Medical Systems, LLC Laura Turner
K192042 07/31/2019 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal Geistlich Pharma AG Marco Steiner
K191957 07/23/2019 BD MAX Vaginal Panel GeneOhm Sciences Canada, Inc. (BD Diagnostics) Katie Edwards
K191748 07/01/2019 Genesys Spine Sacroiliac Joint Fusion System Genesys Spine William W. Sowers
K191923 07/18/2019 EverLift Submucosal Lifting Agent GI Supply Erika Parry
K191835 07/09/2019 CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments Globus Medical, Inc. Kelly J. Baker
K191875 07/12/2019 Owgels Oxygen Concentrator Guangzhou Life Light Electronic Technology Co., Ltd. Erika Meng
K191856 07/11/2019 Compression Therapy Device Guangzhou Longest Science & Technology Co., Ltd. Xiaobing Luo
K191862 07/11/2019 Compression Therapy Device Model LGT-2200SP Guangzhou Longest Science & Technology Co., Ltd. Xiaobing Luo
K191992 07/25/2019 PELNAC Bilayer Wound Matrix Gunze Limited Hidenori Nishioka
K191931 07/19/2019 HardyDisk AST Imipenem/relebactam 10/25?g (IMR10/25) Hardy Diagnostics Anna Klavins
K191841 07/09/2019 Accurate Multi Panel Drug Urine Test Cup Healstone Biotech Inc Bryan Fang
K191938 07/19/2019 FitRelief TENS&EMS Wireless Device Heat In A Click LLC. Guy Levi
K191751 07/01/2019 EM Provisional Hiossen, Inc. Peter Lee
K191801 07/03/2019 PROBEAT-CR Hitachi Ltd. Tomoyuki Seino
K191993 07/25/2019 Yumizen C1200 CRP Horiba ABX SAS Caroline Ferrer
K192028 07/26/2019 Yumizen C1200 CRP Horiba ABX SAS Caroline Ferrer
K191828 07/08/2019 Vathin Video Bronchoscope System Hunan Vathin Medical Instrument Co., Ltd. Yun Feng
K192002 07/26/2019 Lucy Point-of-Care Magnetic Resonance Imaging Device Hyperfine Research, Inc. Brian Sawin
K191821 07/08/2019 Blue Phantom PT IBA Dosimetry GmbH Andreas Suchi
K191994 07/26/2019 ProFound AI Software V2.1 iCAD Inc. Heather Reed
K191868 07/12/2019 iCEWav Neuromonitoring Platform iCE Neurosystems, Inc. Allen Waziri
K192036 07/30/2019 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K191764 07/01/2019 Inion BioRestore Inion Oy Tiina Tyni
K191855 07/10/2019 EmFace Device InMode MD Ltd. Amit Goren
K191939 07/19/2019 Yushan X-Ray Flat Panel Detector InnoCare Optoelectronics Corp. Yumei Cheng
K192049 07/31/2019 Oryx Cervical Plate System Innovasis, Inc. Marshall McCarty
K191880 07/15/2019 Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amanda Babcock
K191895 07/15/2019 Straumann Mini Implants Institut Straumann AG Viviana Horhoiu
K192029 07/30/2019 Straumann PUREloc abutments Institut Straumann AG Giulia Oran
K191741 07/01/2019 Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape Intertape Polymer Inc. Michael Bryant
K191972 07/24/2019 ARIX Wrist System Jeil Medical Corporation Ahhyeon Woo
K192039 07/30/2019 Torc Body Johari Digital Healthcare Limited Pooja Johari
K191933 07/19/2019 COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal Johnson & Johnson Surgical Vision, Inc. Larry Boucher
K191949 07/22/2019 UNFOLDER Vitan Inserter Johnson & Johnson Surgical Vision, Inc. Silvia Jiang-Hughes
K191858 07/11/2019 Pylant Monitor Kal-Med LLC Sandra Greenwood
K191881 07/15/2019 KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun KBL GmbH Ralf de Andreis
K191800 07/03/2019 Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim Kossan International Sdn. Bhd. Cho Sow Fong
K191945 07/22/2019 KOWA nonmyd 8 Kowa Company, Ltd. Nariaki Morita
K191754 07/01/2019 Hair Growth System Kunshan Bella Optical technology Co., Ltd. Wu Xuefeng
K191980 07/24/2019 CLEARFIL MAJESTY ES Flow Kuraray Noritake Dental Inc. Yasujiro Ohara
K191832 07/09/2019 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
K191762 07/01/2019 Magnetic Surgical System Levita Magnetics International Corp. Alberto Rodrigues-Navarro
K191780 07/02/2019 AP50/30 Insufflator with Insuflow Port Lexion Medical LLC Bernard Horwath
K191864 07/12/2019 21HK512D LG Electronics Inc. Jinhwan Jun
K191834 07/09/2019 Stand-Alone ALIF Titanium System Life Spine Inc. Angela Batker
K191927 07/19/2019 Hinged Laminoplasty System Life Spine, Inc. Angela Batker
K191963 07/23/2019 SMR Finned Short Stems LimaCorporate S.p.A Giuseppe Valenti
K191746 07/01/2019 SMR TT Augmented Glenoid System Limacorporate S.p.A Michela Zanotto
K191809 07/05/2019 MTS Imipenem-relebactam 0.002/4-32/4 ?g/mL Liofilchem s. r. l. Fabio Brocco
K191908 07/16/2019 MTS Imipenem 0.016-256 ?g/mL Liofilchem s.r.l. Fabio Brocco
K191742 07/01/2019 ARIES MRSA Assay Luminex Corporation Kate Linak
K191942 07/22/2019 MT One Diamond M&T Srl Firorenzo Rossi
K191998 07/26/2019 Mako Total Hip Application, Mako Total Knee Application MAKO Surgical Corp. Shikha Khandelwal
K191930 07/19/2019 7 mm Extended Length Endoscope Maquet Cardiovascular, LLC Mark Dinger
K191947 07/22/2019 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord Maquet Cardiovascular, LLC. Mark Dinger
K191882 07/15/2019 Masimo Centroid System Masimo Corporation Linus Park
K191935 07/19/2019 Nautilus Smart ECMO Module MC3 Incorporated Adam Viitala
K191816 07/05/2019 M-Vizion Femoral Revision System Extension Medacta International SA Stefano Baj
K191848 07/10/2019 APTUS Wrist Spanning Plates 2.5 Medartis AG Andrea Schweizer
K191958 07/23/2019 Aveta System Meditrina, Inc. Csaba Truckai
K191915 07/17/2019 SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V Medline Industries, Inc Jennifer Mason
K191759 07/01/2019 Medline Quick Switch Valve with ENFit Connector Medline Industries, Inc. Dinah Rincones
K191753 07/01/2019 Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) Medline Industries, Inc. Claire Pigman
K192014 07/29/2019 SYPMHONYÖ OCT System Medos International SARL Sheree Geller
K191943 07/22/2019 SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set Medos International, SARL Daria Bochenek
K191851 07/10/2019 VS3-IR Medtronic Alex Chanin
K191745 07/01/2019 Medtronic Commander Flex Medtronic Care Management Services Gordon Nelson
K191788 07/03/2019 CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System Medtronic Sofamor Danek, USA Inc. Mia Wiggins
K191872 07/12/2019 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution Menicon Co., Ltd. Tetsuji Kawai
K191991 07/25/2019 Ezfil Meta Biomed Co., Ltd. Suk Song Oh
K191829 07/09/2019 Microlife Non-Contact Infrared Forehead Thermometer Microlife Intellectual Property GmbH Gerhard Frick
K191867 07/12/2019 ATLAS Plating System MiRus, LLC Jordan Bauman
K191757 07/01/2019 EUROPA Pedicle Screw System MiRus, LLC Jordan Bauman
K191906 07/16/2019 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
K191898 07/16/2019 Sterile Latex Powder-Free Surgical Gloves Modern Healthcare Corp. Ke-Min Jen
K191869 07/12/2019 Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim Molnlycke Health Care, US LLC Leonard Stewart
K191838 07/09/2019 Clearform Aligners Motor City Lab Works Christina Groth
K191822 07/08/2019 Nano FortiCore, FortiCore Nanovis LLC Matthew Hedrick
K191793 07/03/2019 Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System Nebula Surgical Private Limited Rajat Kumar Khant
K191796 07/03/2019 Neo Cage System Neo Medical S.A. Jonas Larsson
K191889 07/15/2019 NG-Test CARBA 5 NG Biotech Milovan Stankov-Puges
K192045 07/31/2019 Ophthalmic Yag Laser System YC-200 Nidek Co., Ltd. Tsutomu Sunada
K191975 07/24/2019 Elefix V Paste for EEG & EMG Nihon Kohden Corporation Sandra Gadeyne
K191802 07/03/2019 Electric Breast Pump Ningbo Huiyoo Baby Products Co. Ltd. Xiaoping Liu
K191749 07/01/2019 TIGR Matrix Surgical Mesh, TIGR Surgical Mesh Novus Scientific AB Thomas Engstrom
K191974 07/24/2019 NuVasive AttraX Putty NuVasive, Incorporated Jessica LeBlanc
K191955 07/22/2019 Enhanced External Counter Pulsation Device Plus Omay-A Omay(Guangzhou)Med Technologies Co., Ltd. Peixian Su
K191765 07/01/2019 OMNI TiN Coated Apex KneeÖ System OMNI life science, Inc. Christina Rovaldi
K191778 07/02/2019 Omnia Medical VBR Omnia Medical, LLC Troy Schifano
K191907 07/16/2019 OptoWire III Opsens Inc. Marc Chaunet
K191981 07/24/2019 REMEDY Acetabular Cup OsteoRemedies, LLC Eric Stookey
K191990 07/25/2019 OSW Aligner System OSW Manufacturing, LLC Ian Kitching
K191782 07/02/2019 TTC Phantom Intramedullary Nail System Paragon 28, Inc. Eric Lintula
K191783 07/03/2019 Parcus Synd-EZ Ti Parcus Medical, LLC Paul Vagts
K192034 07/30/2019 HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc Pathway, LLC David Stroup
K191946 07/22/2019 Penumbra System Penumbra JET 7X Penumbra, Inc. Micaela Victoria
K191874 07/12/2019 F5 Corpus VS Permobil AB Ivan Fernandez
K191804 07/05/2019 TOMi Scope PhotoniCare, Inc. Ryan Shelton
K191976 07/24/2019 Piper GO-IO Intraosseous Infusion System Piper Access, LLC Jacob Lee
K191854 07/10/2019 Premia Spine XL Instruments Premia Spine, Ltd. Ron Sacher
K191903 07/16/2019 BruxZir GT (Gum Tissue) Color Prismatik Dentalcraft, Inc. Mythili Reguraman
K191740 07/01/2019 DORO LUCENT« iXI and iMRI Headrest System Pro Med Instruments GmbH Sandra Untenberger
K191979 07/24/2019 DORO QR3 XTom Headholder System Pro Med Instruments GmbH Sandra Untenberger
K191853 07/10/2019 Dual-Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang
K191959 07/23/2019 QuantX Breast MRI Biopsy Guidance Plugin Qlarity Imaging Robert Tomek
K191842 07/09/2019 Discovery Pico, Discovery Pico Plus, Discovery Pico Derm Quanta System, S.p.A. Francesco DellÆAntonio
K191962 07/23/2019 Vitra 2 Quantel Medical Bruno Pages
K191861 07/11/2019 Aurora Surgiscope System Rebound Therapeutics Naomi Gong
K191899 07/16/2019 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions Roche Diagnostics Khoa Tran
K191924 07/18/2019 SAFECARE« THC Urine Strip Test Safecare Biotech (Hangzhou) Co., Ltd. Alex Qiu
K192030 07/30/2019 RS80 EVO Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K191813 07/05/2019 MobileDiagnost wDR 2.2 Sedecal SA Maria Luisa Gomez De Aguero
K192011 07/29/2019 PhoeniX Sedecal, SA. M¬ Luisa Gomez de Aguero
K191860 07/11/2019 Sterile Powder-Free Synthetic Rubber SurgeonÆs Glove with Low Dermatitis Potential Semperit Technische Produkte Gesellchaft m.b.H. Andreas Woess
K191769 07/01/2019 ePM Series Patient monitors Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K191894 07/15/2019 Upper Arm Blood Pressure Monitor ShenZhen ZhengKang Technology Co., Ltd. Huayong Yang
K191877 07/15/2019 FLUOROspeed Shimadzu Corporation Toshio Kadowaki
K191840 07/09/2019 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) Shockwave Medical, Inc. Cindy Morrow
K191794 07/03/2019 Vintage Art Universal Shofu Dental Corporation Mauro Malzyner
K191922 07/18/2019 ACUSON P200 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. HyunJung Lee
K191891 07/15/2019 SOMATOM X.cite Siemens Medical Solutions USA, Inc. Tabitha Estes
K192024 07/29/2019 Cemented TSI Hip Stem Signature Orthopaedics Pty Ltd. Declan Brazil
K192013 07/29/2019 VERTICALE« Cervical System Silony Medical GmbH Melanie Lubjuhn
K191760 07/01/2019 PICO 14 Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Sam Greenhalgh
K192044 07/31/2019 4CIS Marlin PEEK ACIF Cage Solco Biomedical Co., Ltd. Hwi-geun Yu
K192047 07/31/2019 RampartÖ One Lumbar Interbody Fusion System Spineology, Inc. Andrew Adams
K191885 07/15/2019 Standard Bougie Standard Bariatrics Alison Sathe
K192001 07/26/2019 Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device Sterilucent, Inc. Peter Kalkbrenner
K191999 07/26/2019 Sterilucent VH2O2 Chemical Indicators Sterilucent, Inc. Peter Kalkbrenner
K192020 07/29/2019 Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label STERIS Corporation Gregory Land
K191916 07/17/2019 Stryker CMF MEDPOR Priority Customized Implant Kit Stryker Leibinger GmbH & Co. KG Gregory Gohl
K191768 07/01/2019 AXS Vecta Aspiration System Stryker Neurovascular Shazia Hakim
K191995 07/26/2019 S4 Screw System Subchondral Solutions, Inc. Sheryl McCoy
K191827 07/08/2019 Sunmed Disposable Angio-Closure Pads Sunny Medical Device (Shenzhen) Co.,Ltd. James Qi Zhang
K191784 07/03/2019 Gabriel Feeding Tube with Balloon, and EnFit Connector Syncro Medical Innovations, Inc. Sabry Gabriel
DEN190034 07/15/2019 Control-IQ Technology Tandem Diabetes Care, Inc. Michael Sarrasin
K192053 07/31/2019 W Zirconia Implants TAV Medical Ltd. Revital Shabtai
K191986 07/25/2019 DESS Dental Smart Solutions Terrats Medical SL Roger Terrats
K191985 07/25/2019 Optilite IgA Kit The Binding Site Group Ltd. Natasha Verhaak
K191936 07/19/2019 iNSitu Total Hip System Thecken Companies, LLC Garrett Spurgeon
K191914 07/17/2019 Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific Cynthia Knapp
K191918 07/18/2019 Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific Cynthia Knapp
K191803 07/03/2019 Orthopedic Fixation Pin Tinavi (Anhui) Medical Technologies Co., Ltd. Jianhua Jiang
K191961 07/23/2019 OrthoGold Tissue Regeneration Technologies John Warlick
K192018 07/29/2019 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Titan Spine, Inc Jane Rodd
K192054 07/31/2019 Endoskeleton TAS Plate Titan Spine, Inc Kelly McDonnell
K191791 07/03/2019 TranS1 Interbody Fusion System TranS1 Kristen Allen
K191913 07/17/2019 TruAbutment DS TruAbutment Inc. Kiyoon Nam
K192023 07/29/2019 Arm Blood Pressure Monitor Truly Instrument Limited Su HaiSen
K191902 07/16/2019 Razor, Everest, U&C Liquid U&C International Co., Ltd. Jong-min Kim
K191932 07/19/2019 MomentumÖ Posterior Spinal Fixation System Ulrich Medical USA Hans Stover
K191929 07/19/2019 UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens UNICON Optical CO., LTD Hsiao-Wei Shen
K191761 07/01/2019 Mobius3D Varian Medical Systems, Inc Peter J. Coronado
K191948 07/22/2019 GlideScope BFlex 5.8 Single-Use Bronchoscope Verathon Medical (Canada) ULC Haleh Ghassemi
K191926 07/18/2019 VITA VIONIC Bond VITA Zanhnfabrik H. Rauter GmbH Co. Bernd Walker
K191837 07/09/2019 UniSmile Clear Aligner System Vitang Technology, LLC Xiangxu Chen
K192008 07/29/2019 LaserShot M, NaviLase Vitrolife GmbH Susanne Schweitzer
K191870 07/12/2019 VV330 Continuous ECG Platform, VivaLNK Adhesive Patch VivaLNK, Inc. Quoi V. Huynh
K191846 07/10/2019 MAXReach Laser Probe Vortex Surgical Inc. Bob Neu
K191773 07/02/2019 GORE BIO-A Tissue Reinforcement W.L. Gore & Associates, Inc. Barbara L. Smith
K191755 07/01/2019 SPAR-K Instruments (for use with Gemini SL Total Knee System) Waldemar Link GmbH & Co. KG Stefanie Fuchs
K191819 07/05/2019 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
K191928 07/19/2019 AccuContour Xiamen Manteia Technology LTD. Lu Xie
K191925 07/18/2019 MATRx Plus Zephyr Sleep Technologies Sabina Bruehlmann
K191900 07/16/2019 Single Use Grasping Forceps Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
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