510(k) Clearances in 2017 — Page 7

3,200 510(k) clearances total

Browse FDA 510(k) clearances granted in 2017. RegDataLab tracks 3,200 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2017 (page 7 of 64)
510(k) clearancesDetails
K173121 — Ankle Fusion Plating SystemIn2Bones Sas Nov 28, 2017
K171226 — TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation Nov 28, 2017
K172030 — Devon 51Devon Medical Products (Jiangsu), Ltd. Nov 27, 2017
K171757 — Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf Of Institut Straumann Ag) Nov 27, 2017
K171488 — PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc. Nov 27, 2017
K171114 — HEALIX ADVANCE KNOTLESS AnchorMedos International SARL Nov 27, 2017
K161855 — LED Curing LightMonitex Industrial Co., Ltd. Nov 27, 2017
K172687 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc. Nov 27, 2017
K172603 — Cerafix Dura SubstituteAcera Surgical, Inc. Nov 27, 2017
K170811 — Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp. Nov 27, 2017
K172300 — CoLink View Plating SystemIn2Bones USA, LLC Nov 27, 2017
K173135 — VariAx 2 SystemStryker GmbH Nov 27, 2017
K173089 — Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning SolutionsBausch & Lomb, Incorporated Nov 27, 2017
K172497 — NuVasive AttraX ScaffoldNu Vasive, Incorporated Nov 24, 2017
K173171 — FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. Nov 24, 2017
K172678 — THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVEShen Wei USA, Inc. Nov 24, 2017
K170578 — True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc. Nov 24, 2017
K172292 — SALUS - Hygiene Instrument Reprocessing ContainerScican , Ltd. Nov 24, 2017
DEN170017 — FilmArray Respiratory Panel 2 plus (RP2plus)Biofire Diagnostics, LLC Nov 24, 2017
K170946 — Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V VariantSkanray Technologies Private Limited Nov 24, 2017
K173372 — ExactechGPS Total Shoulder ApplicationBlue Ortho Nov 24, 2017
K170959 — DIXI Medical Microdeep Depth ElectrodeDixi Medical Nov 24, 2017
K172128 — EsoFLIP® ES-310 Balloon CatheterCrospon, Ltd. Nov 22, 2017
K172462 — OrthAlign Plus SystemOrthalign, Inc. Nov 22, 2017
K173183 — CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation Nov 22, 2017
K172576 — BioHorizons Tapered Short ImplantsBioHorizons Implant Systems, Inc. Nov 22, 2017
K172822 — Azurion series R1.2Philips Medical Systems Nederland B.V. Nov 22, 2017
K172278 — Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated Nov 22, 2017
K172695 — AIR Anterior Array, AIR Posterior ArrayGe Healthcare Coils (Usa Instruments, Inc.) Nov 22, 2017
K170662 — Non Contact Infrared Forehead ThermometerIntrinity Global Limited Nov 22, 2017
K171884 — I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. Nov 22, 2017
K170983 — NIOX VEROCircassia AB Nov 22, 2017
K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep Technologies Nov 22, 2017
K172903 — HemosIL D-Dimer HS 500Instrumentation Laboratory CO Nov 22, 2017
K172229 — GC85ASamsung Electronics Co., Ltd. Nov 22, 2017
K172424 — Velofix™ SA Cervical CageU&I Corporation Nov 22, 2017
K170666 — The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsJoytech Healthcare Co. , Ltd. Nov 22, 2017
K172539 — CereTom EliteNeurologica Corporation, A Subsidiary Of Samsung Electronics Nov 22, 2017
K172007 — CamX Triton HD Proxi HeadDuerr Dental AG Nov 22, 2017
K172111 — Vevazz LEDVevazz, LLC Nov 22, 2017
K172569 — GenePOC CDiffGenepoc, Inc. Nov 22, 2017
K172398 — DENTCA DENTURE TeethDentca, Inc. Nov 22, 2017
K173112 — LAP-iXSejong Medical Co., Ltd. Nov 21, 2017
K172622 — Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals Nov 21, 2017
K171155 — Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. Nov 21, 2017
K172176 — Parkell Universal AdhesiveParkell, Inc. Nov 21, 2017
K173037 — Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection PanelGalil Medical, Inc. Nov 21, 2017
K171719 — Hybrid3DHermes Medical Solutions AB Nov 21, 2017
K171681 — Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB Nov 21, 2017
K171073 — Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. Nov 21, 2017
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