510(k) Clearances in 2017 — Page 48

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 48 of 64)
510(k) clearancesDetails
K163171 — CeraCleanBisco, Inc. Apr 14, 2017
K170582 — Saf-T-Vac Smoke and Fluid EvacuatorSurgical Technology Laboratories, Inc. Apr 14, 2017
K162382 — Smart Dongle Blood Glucose Monitoring SystemTaidoc Technology Corporation Apr 14, 2017
K170610 — PlasmaBlade TMedtronic Advanced Energy Apr 13, 2017
K163443 — Interson USB Ultrasound SystemInterson Corporation Apr 13, 2017
K170055 — CAPRI Corpectomy Cage SystemK2M Apr 13, 2017
K162353 — MICATM Screw SystemWrightmedicaltechnologyinc Apr 13, 2017
K163269 — Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion DeviceTitan Spine, LLC Apr 13, 2017
K162447 — PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerPentax Of America, Inc. Apr 13, 2017
K163461 — Coolief* Cooled RF ProbeHalyard Health, Inc. Apr 13, 2017
K170502 — Patient Positioning SystemForte Automation Systems, Inc. Apr 13, 2017
K161179 — Intelli-OxAir Liquide Healthcare America Corporation Apr 13, 2017
K170214 — Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC Apr 13, 2017
DEN160056 — Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. Apr 12, 2017
K170386 — BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV NeedleBecton Dickinson & Company Apr 12, 2017
K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation Apr 12, 2017
K161114 — HIGH V+Teknimed Sas Apr 12, 2017
K163021 — HAAG-STREIT FUNDUS MODULE 300Optomed OY Apr 11, 2017
K163547 — MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96Neurovirtual USA, Inc. Apr 11, 2017
K162046 — MINNE TIES MMF Suture SystemSummit Medical, Inc. Apr 11, 2017
K170788 — CyberKnife Treatment Delivery SystemAccuray Incorportaed Apr 11, 2017
K160990 — Nova Max Uric Acid Monitoring SystemNova Biomedical Corporation Apr 11, 2017
K170483 — Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated Apr 11, 2017
K170580 — Carestream Vue PACSCarestream Health, Inc. Apr 11, 2017
K163617 — REMbrandtEmbla Systems Apr 11, 2017
K163698 — OptiFix Open Absorbable Fixation System - 20 absorbable fastenersC.R. Bard, Inc. Apr 11, 2017
K170445 — LOGIQ S8GE Healthcare Apr 11, 2017
K163386 — Keos Lumbar IBFDKeos Apr 10, 2017
K163192 — Comfort EC710Alltech Medical Systems America, Inc. Apr 10, 2017
K163125 — geko™ T-2 and geko™ Plus R-2 Neuromuscular StimulatorsFirstkind Limited Apr 10, 2017
K162068 — ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie Apr 10, 2017
K163271 — i-Stat Alinity System with i-Stat Glucose testAbbott Point Of Care, Inc. Apr 10, 2017
K162968 — VORTRAN GO2VENTVortran Medical Technology 1, Inc. Apr 10, 2017
K162642 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. Apr 10, 2017
K170724 — NeuroBlate SystemMonteris Medical, Apr 7, 2017
K170059 — Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc. Apr 7, 2017
K170598 — ZeroWire MobileNds Surgical Imaging, LLC Apr 7, 2017
K152192 — LED Curing LightMonitex Industrial Co., Ltd. Apr 7, 2017
K160694 — Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. Apr 7, 2017
K163372 — RX Takeru Balloon Dilatation CatheterKANEKA Corporation Apr 7, 2017
K162838 — Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc. Apr 7, 2017
K162877 — VOCSN Unified Respiratory SystemVentec Life Systems, Inc. Apr 7, 2017
K163265 — Kepler IIOrbbo Surgical, LLC Apr 7, 2017
K160549 — MEDICAL DIODE LASER SYSTEMSWuhan Gigaa Optronics Technology Co., Ltd. Apr 7, 2017
K163144 — gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)Gke-GmbH Apr 7, 2017
K163361 — ANTHEM™ Fracture SystemGlobus Medical, Inc. Apr 7, 2017
K170813 — ORTHOPANTOMOGRAPH OP 3DPalodex Group OY Apr 7, 2017
K162203 — POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. Apr 6, 2017
K163101 — CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetMicrogenics Corporation Apr 6, 2017
K161599 — UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. Apr 6, 2017
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