510(k) Clearances in 2017 — Page 46

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 46 of 64)
510(k) clearancesDetails
K162732 — Exactech® Alteon® HA Femoral StemExactech, Inc. Apr 26, 2017
K163332 — Apex Revision Knee SystemOmnilife Science Apr 26, 2017
K170942 — The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP Apr 26, 2017
K162237 — XO1 Knee Balancing SystemXpandortho, Inc. Apr 25, 2017
K162799 — CliniviewPalodex Group OY Apr 25, 2017
K160670 — ET US SS Prosthetic systemOsstem Implant Co., Ltd. Apr 25, 2017
K170511 — NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC Apr 25, 2017
K170936 — Cutera enlighten III Laser SystemCutera, Inc. Apr 25, 2017
K163675 — Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. Apr 25, 2017
K162661 — SavDenTM MTA Root Canal Filling MaterialsTyds Biotech Incorporation Apr 25, 2017
K170260 — BC-001+ Acne PurifierOriental Inspiration Limited Apr 25, 2017
K163507 — Triton Sponge SystemGauss Surgical, Inc., Apr 25, 2017
K170132 — MyoCycle Home, MyoCycle ProMyolyn, LLC Apr 25, 2017
K162067 — VX130 Ophthalmic Diagnostic DeviceLuneau Sas Apr 24, 2017
K170536 — ECG Disposable Lead WireAPK Technology Co., Ltd. Apr 24, 2017
K160499 — Apnea Risk Evaluation System (ARES), Model 620Watermark Medical Apr 24, 2017
K170887 — EVOS Small Fragment Plating SystemSmith & Nephew, Inc. Apr 24, 2017
K162441 — PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc. Apr 24, 2017
K170858 — FDR AQRO (DR-XD 1000)Fujifilm Medical Systems U.S.A, Inc. Apr 24, 2017
K170012 — Foot and Hand MotionNewclip Technics Apr 24, 2017
K163650 — ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc Apr 24, 2017
K162154 — Pantheon Medical Balanced Plating SystemPantheon Medical Apr 24, 2017
K162748 — MindMotionPROMindmaze SA Apr 24, 2017
DEN160030 — Oculeve Intranasal Tear Neurostimulator DeviceOculeve, Inc. Apr 24, 2017
K162104 — C-Flex Ureteral Stent SetCook Incorporated Apr 24, 2017
K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP)Randox Laboratories Limited Apr 21, 2017
K170221 — syngo.CT Cardiac PlanningSiemens Healthcare GmbH Apr 21, 2017
K170869 — LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien Apr 21, 2017
K170953 — Tomcat Cervical Spinal SystemChoicespine, LP Apr 21, 2017
K160179 — VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. Apr 21, 2017
K163537 — Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC Apr 21, 2017
K163645 — DERMABOND PRINEO Skin Closure SystemEthicon, LLC Apr 21, 2017
K170716 — PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc. Apr 21, 2017
K163516 — Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen Of Troy Company Apr 21, 2017
K163088 — TSIII BA FixtureOsstem Implant Co., Ltd. Apr 21, 2017
K170537 — Nexxis OR, NexxisBarco N.V. Apr 21, 2017
K162930 — Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc. Apr 21, 2017
K163255 — CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological MonitorCaretaker Medical, LLC Apr 21, 2017
K162294 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGSBrightway Holdings Sdn. Bhd. Apr 21, 2017
K170721 — Cut-Vac Lighted Smoke Evacuation Electrosurgical PencilPrecision Surgical, LLC Apr 21, 2017
K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging SystemSybron Dental Specialties Apr 21, 2017
K162655 — StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc. Apr 21, 2017
K170358 — joimax Endovapor 2Joimax GmbH Apr 21, 2017
K170865 — EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. Apr 21, 2017
K162151 — PENTAX Medical ENT Video Imaging SystemPentax Of America, Inc. Apr 20, 2017
K163677 — Ortho System3Shape A/S Apr 20, 2017
K162722 — HyperSenseGe Medical Systems, LLC Apr 20, 2017
K162236 — Ax Stand-Alone ALIF SystemInnovasis, Inc. Apr 20, 2017
K162607 — BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 20, 2017
K163235 — HEM-9210TOmron Healthcare, Inc. Apr 20, 2017
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