510(k) Clearances in 2017 — Page 49

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 49 of 64)
510(k) clearancesDetails
K160323 — FlowKeepersDk Electronics, LLC Apr 6, 2017
DEN160026 — 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia23AndMe, Inc. Apr 6, 2017
K162488 — Optiflux dialyzerFresenius Medical Care North America Apr 6, 2017
K163220 — Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc. Apr 6, 2017
K163233 — MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension CatheterMivi Neuroscience, Inc. Apr 6, 2017
K162617 — NobleStitch ELNobles Medical Technologies Ii, Inc. Apr 6, 2017
K163246 — Leva Anterior Expandable Spacer SystemSpine Wave, Inc. Apr 6, 2017
K170700 — Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. Apr 6, 2017
K170171 — IOLMaster 700Carl Zeiss Meditec, AG Apr 6, 2017
K162925 — AcQGuide Steerable SheathAcutus Medical, Inc. Apr 6, 2017
K163469 — ViziShot 2 FLEXOlympus Surgical Technologies America Apr 6, 2017
K162287 — Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. Apr 6, 2017
K170088 — Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent FilmMedela AG Apr 6, 2017
K170385 — CORE M2 Vascular SystemVolcano Corporation Apr 6, 2017
K163256 — Dual Mode Infrared ThermometerIntelliworks, LLC Apr 6, 2017
K162927 — PRECICE UNYTE CoCr SystemNuvasive Specialized Orthopedics, Inc. Apr 6, 2017
K153763 — Howell Biliary Aspiration NeedleWilson-Cook Medical, Inc. Apr 6, 2017
K161829 — Huvitz Imaging SystemHuvitz Co., Ltd. Apr 6, 2017
K163274 — AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. Apr 5, 2017
K170837 — Nio Color 3MP (MDNC-3421)Barco N.V. Apr 5, 2017
K163363 — SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc. Apr 5, 2017
K161332 — NILE Proximal Fixation Spinal SystemK2M, Inc. Apr 5, 2017
K161982 — C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group Apr 5, 2017
K162567 — ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho Apr 5, 2017
K163076 — Segment CMRMedviso AB Apr 5, 2017
K170677 — Neurovision Nerve Locator Monitor (Nerveana), EMGView SoftwareNeurovision Medical Product, Inc. Apr 5, 2017
K161919 — UltraScan 650Cyberlogic, Inc. Apr 5, 2017
K161712 — Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. Apr 5, 2017
K163711 — IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. Apr 5, 2017
K161341 — LIFESYS PACSLifetrack Medical Systems, Inc. Apr 5, 2017
K170719 — Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. Apr 5, 2017
K163509 — XprESS ENT Dilation SystemEntellus Medical, Inc. Apr 5, 2017
K170668 — HeartSpan Steerable Sheath IntroducerMerit Medical Systems, Inc. Apr 5, 2017
K163435 — Entellus Medical Reinforced Anesthesia NeedleEntellus Medical, Inc. Apr 5, 2017
K170456 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions Apr 5, 2017
K170377 — TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MMRichard Wolf Medical Instruments Corporation Apr 5, 2017
K163303 — OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC Apr 4, 2017
K163459 — Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation Apr 4, 2017
K170040 — BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie Apr 4, 2017
K170678 — Beta-CrossLaps CalCheck 5Roche Diagnostics Apr 4, 2017
K170411 — ER-REBOA CatheterPrytime Medical Devices, Inc. Apr 4, 2017
K170731 — System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightVATECH Co., Ltd. Apr 4, 2017
K162206 — Zavation IBFZavation, LLC Apr 4, 2017
K163221 — Mazor XMazor Robotics , Ltd. Apr 4, 2017
K163458 — Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. Apr 4, 2017
K163613 — Bluephase Style 20iIvoclar Vivadent, AG Apr 4, 2017
K170560 — SAGE Vitrification Kit and SAGE Vitrification Warming KitCooperSurgical, Inc. Apr 4, 2017
K170347 — CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA Apr 4, 2017
K170315 — Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. Apr 4, 2017
K162782 — iHelmet Hair Growth SystemSlinph Technologies Co., Ltd. Apr 4, 2017
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