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
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
K191817 07/05/2019 ActivOrtho Continuous Compression Screw System ActivOrtho, Inc. Paul Hindrichs
K191884 07/15/2019 DR 100s Agfa N.V. Wim Govaerts
K191795 07/03/2019 AOCup Lens Case with AODisc Alcon Laboratories, Inc. Katryna Warren
K191843 07/09/2019 Ceramill A-Temp Amann Girrbach AG Debora Engel
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
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
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
K192012 07/29/2019 Capillus 112, Capillus 244 Capillus Patricia Schnoor
K191797 07/03/2019 BiomarC Fiducial Marker Carbon Medical Technologies Eric Furlich
K191811 07/05/2019 Catalyst OrthoScience CSR Shoulder System Catalyst OrthoScience, Inc. Dale Davison
K191810 07/05/2019 Curiteva Pedicle Screw System Curiteva, Inc. Eric Linder
K192010 07/29/2019 SmoothSkin BARE+ CyDen Limited Adam Stephens
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
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
K191844 07/09/2019 Fidmi Low Profile Enteral Feeding Device Fidmi Medical Ltd Shahar Millis
K191747 07/01/2019 FUJIFILM Duodenoscope Model ED-580XT FUJIFILM Corporation Randy Vader
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
K191748 07/01/2019 Genesys Spine Sacroiliac Joint Fusion System Genesys Spine William W. Sowers
K191835 07/09/2019 CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments Globus Medical, Inc. Kelly J. Baker
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
K191801 07/03/2019 PROBEAT-CR Hitachi Ltd. Tomoyuki Seino
K191993 07/25/2019 Yumizen C1200 CRP Horiba ABX SAS Caroline Ferrer
K191994 07/26/2019 ProFound AI Software V2.1 iCAD Inc. Heather Reed
K192036 07/30/2019 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K191764 07/01/2019 Inion BioRestore Inion Oy Tiina Tyni
K191939 07/19/2019 Yushan X-Ray Flat Panel Detector InnoCare Optoelectronics Corp. Yumei Cheng
K191741 07/01/2019 Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape Intertape Polymer Inc. Michael Bryant
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
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
K191780 07/02/2019 AP50/30 Insufflator with Insuflow Port Lexion Medical LLC Bernard Horwath
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
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
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
K191848 07/10/2019 APTUS Wrist Spanning Plates 2.5 Medartis AG Andrea Schweizer
K191958 07/23/2019 Aveta System Meditrina, Inc. Csaba Truckai
K191943 07/22/2019 SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set Medos International, SARL Daria Bochenek
K191757 07/01/2019 EUROPA Pedicle Screw System MiRus, LLC Jordan Bauman
K191822 07/08/2019 Nano FortiCore, FortiCore Nanovis LLC Matthew Hedrick
K191889 07/15/2019 NG-Test CARBA 5 NG Biotech Milovan Stankov-Puges
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
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
K191854 07/10/2019 Premia Spine XL Instruments Premia Spine, Ltd. Ron Sacher
K191853 07/10/2019 Dual-Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang
K191842 07/09/2019 Discovery Pico, Discovery Pico Plus, Discovery Pico Derm Quanta System, S.p.A. Francesco DellÆAntonio
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
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
K192047 07/31/2019 RampartÖ One Lumbar Interbody Fusion System Spineology, Inc. Andrew Adams
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
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
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
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
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
K192021 07/29/2019 NCB Polyaxial Locking Plate System Zimmer GmbH Annemie Rehor Kausch
K191781 07/02/2019 Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System Zimmer GmbH Roberto Tommasini


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