FDA 510(k) Applications Received During April, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K180874 04/03/2018 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield 3M Health Care Linda Johnsen
K181041 04/19/2018 7D Surgical System Cranial Application 7D Surgical Inc. Daniel Ziskind
K180948 04/11/2018 TruDi NAV Suction Instruments Acclarent, Inc. Leena Sorathia
K181077 04/24/2018 ActiGraph CentrePoint Insight Watch ActiGraph Brian Bell
K180988 04/16/2018 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini
K181035 04/18/2018 AOS Small Fragment Plating System Lite Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla
K180914 04/09/2018 Aesculap Slim Clip Applier Aesculap, Inc. Paul Amudala
K181044 04/19/2018 400um Perforator and Accessory Vein Ablation Kit AngioDynamics, Inc. Deepa R. Godhiya
K180848 04/02/2018 AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches ArthroCare Corporation Shruthi Bhat
K181139 04/30/2018 OLYMPIC Posterior Spinal Fixation System Astura Medical, LLC Parker Kelch
K181092 04/25/2018 CHROMID CARBA agar (CARB) bioMerieux SA Asa Karlsson
K180936 04/10/2018 ETEST Telavancin (TLA) (0.002-32 ug/mL) bioMerieux SA Asa Karlsson
K180943 04/10/2018 BioWaveGO Biowave Corporation Bradford Siff
K180864 04/02/2018 WATCHMAN TruSeal Access System Boston Scientific Nikki M Ibis
K181042 04/19/2018 Ultra ICE Plus û PI 9 MHz Peripheral Imaging Catheter Boston Scientific Corporation Jennifer L. Foley
K181012 04/17/2018 BUHLMANN fCAL ELISA BUHLMANN Laboratories AG Alicja Ritz
K180990 04/16/2018 TirboLOX-L Lumbar IBFD Captiva Spine, Inc. Jackie Ferro
K180858 04/02/2018 CALLISTO eye Carl Zeiss Meditec AG Christian Muenster
K180959 04/12/2018 Phenom 27 Catheter Cathera, Inc. Victor Ham
K181080 04/24/2018 McKesson Cardiology Change Healthcare Israel Ltd. Nadia Marchant
K180974 04/13/2018 CBit Series Digital Color Doppler Ultrasound System CHISON Medical Technologies Co., Ltd. Qifei Liu
K181007 04/17/2018 Cianna Medical SAVI Scout Reflector and SAVI Scout System Cianna Medical, Inc. Gary Mocnik
K180906 04/06/2018 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc. Emmanuel Nyakako
K180868 04/03/2018 Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set Cook Ireland Jacinta Kilmartin
K181085 04/25/2018 LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated Covidien James R. Davis
K180915 04/09/2018 Sonicision Reusable Sterilization Tray Covidien Candice Bautista-Biddle
K181020 04/17/2018 Cytosponge Cell Collection Device Covidien llc Rachel Silva
K180891 04/05/2018 EVOL Spinal Interbody System, EVOS Lumbar Interbody System Cutting Edge Spine, LLC Kyle Kuntz
K181122 04/30/2018 CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp. Hemang Kotecha
K181024 04/18/2018 DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips DFI Co., Ltd. Bella Cho
K180932 04/10/2018 Diamond Orthopedic Bone Fixation Screws and Pins Diamond Orthopedic, LLC Roy Bivens
K180862 04/02/2018 Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System Edan Instruments, Inc Alice Yang
K180961 04/12/2018 RadiForce MX194 EIZO Corporation Hiroaki Hashimoto
K181095 04/26/2018 RF-Relief EL Global Trade Ltd Martin Gurovich
K180853 04/02/2018 EP GranulesÖ BVF Elute, Inc. Kirk Andriano
K180904 04/06/2018 Sniper Infusion Catheter with Balloon Occlusion Embolx, Inc Greg Haistead
K180930 04/10/2018 EMPOWR VVC TIBIAL INSERT Encore Medical, L.P. Teffany Hutto
K180910 04/06/2018 ULTRAPRO Mesh and ULTRAPRO ADVANCED Ethicon Inc Melina Escobar
K181067 04/23/2018 AlignX Ankle Fusion System Extremity Medical, LLC Brian Smekal
K181059 04/23/2018 geko T-3 Neuromuscular Stimulator Firstkind Limited Neil Buckley
K181108 04/27/2018 Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K181011 04/17/2018 AIM2 GC America Inc. Mark Heiss
K180995 04/16/2018 Vscan Extend GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K181068 04/23/2018 CREO« Stabilization System, REVERE« Stabilization System Globus Medical Inc. Kelly J. Baker
K181019 04/17/2018 Diode Laser System Guangzhou Huafei Tongda Technology Co., Ltd. Liu Pengqi
K181130 04/30/2018 Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs Hebei Titans Hongsen Medical Technology Co., LTD. Shaozhang Nan
K180901 04/06/2018 Low Dose CT Lung Cancer Screening Option Hitachi Healthcare Americas Doug Thistlethwaite
K181121 04/30/2018 Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro Home Well Trading LTD Martin Gurovich
K180849 04/02/2018 Vinyl Examination Glove (Clear, Non-Colored) Huifu Trading Co., Ltd Kangkang Wang
K180866 04/02/2018 CareSens S Fit Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K181113 04/27/2018 CoLinkÖ Afx Plating System In2Bones USA, LLC Rebecca Wahl
K181115 04/27/2018 CxHA PEEK Cervical IBF System Innovasis, Inc. Marshall McCarty
K181063 04/23/2018 KestrelÖ Buttress Plate System Innovasis, Inc. Marshall McCarty
K180975 04/13/2018 QUANTA Flash HMGCR Reagents Inova Diagnostics, Inc. Roger Albesa
K180847 04/02/2018 Neutrogena Light Therapy Acne Mask+ Johnson & Johnson Consumer Inc. Timothy Kline
K180856 04/02/2018 Neutrogena Light Therapy Aging Mask+ Johnson & Johnson Consumer, Inc. Cindy R. Abraham
K181119 04/27/2018 Range (Denali and Mesa) Spinal Systems K2M, Inc. Nancy Giezen
K180977 04/13/2018 KARL STORZ New Generation Trocars KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin
K181015 04/17/2018 Braun BFH175 Infrared Forehead Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K180855 04/02/2018 Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System KCI USA, Inc. Kimberly McCoy
K180962 04/12/2018 KLS Martin Individual Patient Solutions KLS-Martin L.P. Jennifer Damato
K180970 04/13/2018 Disposable guides KDNG00 Koelis Pauline Nicole
K180967 04/13/2018 Dental Diode Laser System Lazon Medical Laser Co., Ltd. Gen Cheng
K180885 04/04/2018 HairMax Laser Lexington International, LLC David Michaels
K180886 04/04/2018 Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL Liofilchem s. r. l. Fabio Brocco
K180907 04/06/2018 HORIZON TMS Therapy System Magstim Company Ltd. Tom Campbell
K181009 04/17/2018 APTUS CMC-I Fusion Plate System Medartis AG Andrea Schweizer
K181132 04/30/2018 Tri-Ad 2.0 Adams Tricuspid Band Medtronic Tracy Gray
K181001 04/16/2018 Medtronic Confida Brecker Guidewire Medtronic Core Valve, LLC. Gerardine Drummond
K181060 04/23/2018 Solitaire 2 and Solitaire Platinum Revascularization Device Medtronic Neurovascular Amnon Talmor
K180851 04/02/2018 VERTEXÖ Reconstruction System Medtronic Sofamor Danek USA, Inc Ankit K Shah
K181111 04/27/2018 Navigated INFINITY Instruments Medtronic Sofamor Danek USA, Inc. Tejas Patel
K180873 04/03/2018 Medtronic Model 53401 External Pulse Generator (EPG) Medtronic, Inc. Brenna Loufek
K181023 04/17/2018 Mozec û Rx PTCA Balloon Dilatation Catheter, Mozec NC û Rx PTCA Balloon Dilatation Catheter Meril Life Sciences Private Limited Utpal Thakor
K181062 04/23/2018 Ultra Facial Toning System Micro Current Technology, Inc. David Suzuki
K181017 04/10/2018 Free Testosterone AccuBind ELISA Test System Monobind Inc. Anthony Shatola
K181025 04/18/2018 I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System Neuro Kinetics, Inc. Robin C. Ashmore
K180908 04/06/2018 Irrigation Tubing Bipolar Cord Set New Deantronics Taiwan Ltd Jane Liu
K181043 04/19/2018 StatStrip Glucose Hospital Meter System Nova Biomedical Corporation John Mchale
K180895 04/05/2018 Alleye Oculocare Medical AG Lucas Bachmann
K180993 04/16/2018 Beacon Advanced CO2 Laser System OmniGuide, Inc Sam Wade
K180921 04/09/2018 Sapphire II PRO Balloon Dilatation Catheter OrbusNeich Medical Trading Inc. John Pazienza
K180947 04/11/2018 Orthopantomograph OP 3D PaloDEx Group Oy Terho Turkumaki
K180957 04/12/2018 exGraft, exGraft Carbon ePTFE Vascular Grafts PECA Labs Doug Bernstein
K180939 04/10/2018 Indigo Aspiration System - Modified 110 Aspiration Tubing Penumbra, Inc. Richard Kimura
K180923 04/09/2018 Personal Lubricating Jelly Perrigo New York, Inc. Karen Dombrowski
K180976 04/13/2018 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels Pixxgen Corporation John Ross
K180876 04/03/2018 DTRAX Spinal System Providence Medical Technology, Inc. Edward Liou
K181050 04/20/2018 Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) Qualimed SRL Tereza Uhrova
K180922 04/09/2018 Empower H100, Cyber Ho 100, Litho 100 quanta system spa Francesco Dell'Antonio
K181029 04/18/2018 Solana Bordetella Complete Assay Quidel Corporation Ronald H. Lollar
K180989 04/16/2018 PEDRA-17F Digital Flat Panel X-ray Detector Radisen Inc. John Lim
K181030 04/18/2018 Rubicon Lumbar Interbody Fusion System Rubicon Spine, LLC Mike Boyer
K180960 04/12/2018 FIXIT / ComposiTCP Threaded Anchor System S.B.M. SAS Sciences for Bio Materials Anne Cospin-Latapie
K180883 04/04/2018 5D Viewer Samsung Medison Co., Ltd. Ji Yea Lee
K181079 04/24/2018 SeaSpine Regatta Lateral System SeaSpine Orthopedics Corporation Gina Flores
K180926 04/09/2018 uMR 560 Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K180925 04/09/2018 uMR 570 Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K181051 04/20/2018 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm Shape Memory Medical Meghan Reu
K181104 04/26/2018 Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style Shenzhen Combei Technology CO., LTD Kevin Fong
K180912 04/06/2018 TE7/TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Yang Zhaohui
K180956 04/12/2018 Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang
K180958 04/12/2018 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable Shockwave Medical, Inc. Cindy Morrow
K181002 04/16/2018 Atellica IM BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics Inc. Fatima Pacheco
K181082 04/24/2018 ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) Siemens Healthcare Diagnostics, Inc. Kathleen Dray-Lyons
K181098 04/26/2018 ACUSON SC2000 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Christine Dunbar
K180963 04/12/2018 ROCCIA ALIF, ROCCIA TLIF Silony Medical GmbH Bircan Tasdelen
K181074 04/24/2018 Simple Science Antimicrobial Facial and Eyelid Cleanser Simple Science LLC Eoin Croke
K181083 04/24/2018 Stryker All-PEEK Knotless Anchor System Stryker Katie Farraro
K181014 04/17/2018 Tritanium PL Cage Stryker Spine Travis Catania
K181134 04/30/2018 GòUòM HYDRAL Dry Mouth Oral Gel, GòUòM HYDRAL Dry Mouth Oral Rinse, GòUòM HYDRAL Dry Mouth Oral Spray Sunstar Americas Inc Liz Bastian
K180985 04/13/2018 Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses Supervision Optimax SDN BHD Yap Peak Geeh
K180937 04/10/2018 Graftgun Universal Graft Delivery System Surgentec, LLC Boca Raton
K181094 04/25/2018 Polydioxanone Surgical Scaffold Surgical Innovation Associates, Inc. Alexei Mlodinow
K181093 04/25/2018 SyMRI SyntheticMR AB Maria Almesaker
K180950 04/11/2018 Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) Terumo Cardiovascular Systems Corporation Adam Pickholtz
K180850 04/02/2018 re.t.a Reuseable Tampon Applicator Thinx, Inc. Kerrie Timmons
K180929 04/09/2018 Klassic HD« Hip System Total Joint Orthopedics, Inc. Chris Weaber
K181136 04/30/2018 CS 9600 Trophy Marie-Pierre Labat-Camy
K180888 04/04/2018 LYFT Uplevity, Inc. Thomas Kraft
K180900 04/06/2018 LED Light Therapy Device Uvbiotek, LLC Dave Oberhelman
K181032 04/18/2018 Halcyon Varian Medical Systems Inc. Peter J. Coronado
K180913 04/09/2018 VSI Micro-Introducer Kit Vascular Solutions, Inc. Jake Schultz
K181003 04/16/2018 VIVIX-S 1717V Vieworks Co., Ltd. Jordin Kim
K180911 04/06/2018 Visura Technologies TEECAD System Visura Technologies, LLC Eric Sandberg
K181013 04/17/2018 Fever Scout VivaLnk Inc. Christine Kuo
K180854 04/02/2018 Voyager Trajectory Array Guide (V-TAG) Voyager Therapeutics, Inc. Lynn E Bayless
K181016 04/17/2018 Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System Welch Allyn, Inc. Megan Pellenz
K180986 04/16/2018 XableCath Support Catheter Product Family XableCath, Inc. Rick Gaykowski
K181069 04/23/2018 Disposable Insulin Pen Needle Zhejiang Kindley medical devices Co.,Ltd Yong Zhang
K180861 04/02/2018 Vinyl Examination Glove (Clear, Non-Colored) Zhicheng Trading Co., Ltd. Chong Zhao
K180865 04/02/2018 ZMI Self-Adhesive Electrodes ZMI Electronics, Ltd. Wayne Chen


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