510(k) Clearances in 2017 — Page 57

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 57 of 64)
510(k) clearancesDetails
K163298 — Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mLLiofilchem S.R.L. Feb 22, 2017
K151834 — BEMER Classic Set, BEMER Pro-SetBemer Int AG Feb 22, 2017
K161534 — EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG Feb 22, 2017
K162929 — Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask TrackerStryker Corporation Feb 22, 2017
K163041 — Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin EPt. Medisafe Technologies Feb 22, 2017
K170202 — Aquarius 8600Imaging Dynamics Company , Ltd. Feb 22, 2017
K163126 — Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)Blue Sail Medical Co.,Ltd Feb 22, 2017
K162911 — Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation Feb 22, 2017
K163535 — my Patch slDms-Service, LLC Feb 22, 2017
K152022 — SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-SpacerGlobus Medical, Inc. Feb 22, 2017
K170258 — SpeedLyser Infusion Catheter KitAngioDynamics, Inc. Feb 21, 2017
K163051 — ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC Feb 21, 2017
K163317 — ELECTROmaticKaltenbach & Voigt Gmgh Feb 21, 2017
K162391 — AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc. Feb 21, 2017
K161987 — UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - SuprastructureDio Corporation Feb 21, 2017
K163045 — Omron HEM-6400T-Z Wrist Blood Pressure MonitorOmron Healthcare, Inc. Feb 21, 2017
K163091 — VibraPEPMedica Holdings, LLC Feb 21, 2017
K162841 — VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH Feb 21, 2017
K161894 — SurgTech Trauma SystemSurgtech, Inc. Feb 21, 2017
K163273 — TRU LegionellaMeridian Bioscience, Inc. Feb 21, 2017
K162032 — Arrowhead Mini-Rail FixatorArrowhead De, LLC Feb 21, 2017
K161120 — SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A. Feb 21, 2017
K162565 — VIA 17 MicrocatheterSequent Medical, Inc. Feb 18, 2017
K163272 — AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation Feb 18, 2017
K163037 — Intra medullary endo-transilluminating device (iMET device)WeMED Bio-Tech, Inc. Feb 17, 2017
K163651 — ExpressBraid Graft ManipulationBiomet Manufacturing Corp Feb 17, 2017
K162824 — Z-Span Plate SystemZavation, LLC Feb 17, 2017
K161953 — ReDe MaskTereopneuma Feb 17, 2017
K162875 — Sentry IVC filterNovate Medical , Ltd. Feb 17, 2017
K161411 — Care Cycle Connect ApplicationRespironics, Inc. Feb 17, 2017
K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter SetCook Incorporated Feb 17, 2017
K163260 — SeptiCyte LABImmunexpress, Inc. Feb 17, 2017
K160799 — GenNarinoSaliwell , Ltd. Feb 17, 2017
K162281 — CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia Feb 17, 2017
K162833 — VitriGuardOrigio A/S Feb 16, 2017
K162849 — Huvex Interspinous Fixation SystemDio Medical Co., Ltd. Feb 16, 2017
K153561 — AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemAndon Health Co, Ltd. Feb 16, 2017
K161764 — SLIT LAMP, Model: YF-100Chongqing Yeasn Science-Technology Co., Ltd. Feb 16, 2017
K162007 — STERRAD NX SterilizerAdvanced Sterilization Products Feb 16, 2017
K161616 — DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression ScrewSynthes USA Products, LLC Feb 16, 2017
K163602 — Kepler I Cervical Plate SystemOrbbo Surgical, LLC Feb 16, 2017
K162570 — Miromatrix Biological Mesh TWMiromatrix Medical, Inc. Feb 16, 2017
K170103 — Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. Feb 16, 2017
K163374 — ALLY™ Facet ScrewsProvidence Medical Technology, Inc. Feb 16, 2017
K161437 — VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)bioMerieux, Inc. Feb 16, 2017
K163165 — AM-100BTL Industries, Inc. Feb 16, 2017
K163549 — ClotTriever Thrombectomy SystemInari Medical, Inc. Feb 16, 2017
K161996 — 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSEAmend Surgical, Inc. Feb 16, 2017
K162481 — RF1400 Active Compression WrapRecovery Force, LLC Feb 16, 2017
K170170 — Valleylab FT10 Electrosurgical PlatformCovidien, LLC Feb 16, 2017
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