510(k) Clearances in 2017 — Page 47

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 47 of 64)
510(k) clearancesDetails
K163160 — Sterile Single-use Infusion SetJiangxi Hongda Medical Equipment Group , Ltd. Apr 20, 2017
K162901 — Penumbra 3D Revascularization DevicePenumbra, Inc. Apr 20, 2017
K162354 — Sniper Staple SystemTrilliant Surgical, Ltd. Apr 20, 2017
K152830 — K3Osstem Implant Co., Ltd. Apr 20, 2017
K161910 — Cardinal Health Sterilization WrapCardinal Health200, LLC Apr 20, 2017
K162017 — Ross Ru Wound Dressing GelBiotd S.A. Apr 20, 2017
K163415 — SlimShape SystemSyneron Medical, Ltd. Apr 20, 2017
K163690 — DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 20, 2017
K163708 — QiF Blood and Fluid WarmerQuality IN Flow , Ltd. Apr 20, 2017
K161884 — Ortho System3Shape A/S Apr 19, 2017
K160502 — TEG 6s Hemostasis SystemHaemonetics Corporation Apr 19, 2017
K170215 — LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDockPatient Pocket, LLC Apr 19, 2017
K163383 — GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating SystemGreens Surgicals Pvt. , Ltd. Apr 19, 2017
K170052 — Stellaris Elite vision enhancement systemBausch+Lomb Apr 19, 2017
K160680 — VisioFocus Mini, VisioFocus SmartTecnimed S.R.L. Apr 19, 2017
K160967 — Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. Apr 18, 2017
K170120 — EndoRotorInterscope, Inc. Apr 18, 2017
K170406 — Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC Apr 18, 2017
K163387 — PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited Apr 18, 2017
K162297 — Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetDiazyme Laboratories Apr 18, 2017
K170247 — Lacriflow CLKaneka Pharma America, LLC Apr 18, 2017
K162296 — OmniPod Insulin Management SystemInsulet Corporation Apr 18, 2017
K170593 — Mako Total Hip ApplicationMako Surgical Corp. Apr 18, 2017
K162087 — NovoGroOsteonovus, Inc. Apr 18, 2017
K163523 — ECHELON CIRCULAR Powered StaplerEthicon Endo-Surgery, LLC Apr 18, 2017
K170533 — Model 330 Multifunction AspiratorZOLL Medical Corporation Apr 18, 2017
K170833 — EndoFLIP® System with FLIP Topography moduleCrospon, Ltd. Apr 17, 2017
K162361 — Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. Apr 17, 2017
K163484 — Paxman Scalp CoolerPaxman Coolers Limited Apr 17, 2017
K163001 — PowerFlow Apheresis I.V. PortC.R. Bard, Inc. Apr 17, 2017
K162108 — Pressio 2 ICP Monitoring SystemSophysa SA Apr 17, 2017
K162621 — Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual WheelchairInvacare Corporation Apr 17, 2017
K170266 — Palisade™ Pedicular Fixation SystemSpineology, Inc. Apr 14, 2017
K162382 — Smart Dongle Blood Glucose Monitoring SystemTaidoc Technology Corporation Apr 14, 2017
DEN150048 — gammaCore Non-invasive Vagus Nerve StimulatorElectrocore, LLC Apr 14, 2017
K162438 — Sofia Influenza A+B FIA on Sofia 2Quidel Corporation Apr 14, 2017
K163329 — Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC Apr 14, 2017
K163656 — Hoffmann LRF SystemStryker GmbH Apr 14, 2017
K161743 — Etgar Dental Implant SystemEtgar Medical Instruments, Ltd. Apr 14, 2017
K162636 — Marco Ultra M3, Marco Ultra M4Takagi Seiko Co., Ltd. Apr 14, 2017
K162785 — Velox Nebulizer SystemPari Respiratory Equipment, Inc. Apr 14, 2017
K162891 — Complete Control SystemCoapt, LLC Apr 14, 2017
K163381 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC Apr 14, 2017
K162517 — Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. Apr 14, 2017
K170268 — Fortress™ Pedicular Fixation SystemSpineology, Inc. Apr 14, 2017
K161794 — CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. Apr 14, 2017
K163171 — CeraCleanBisco, Inc. Apr 14, 2017
K170582 — Saf-T-Vac Smoke and Fluid EvacuatorSurgical Technology Laboratories, Inc. Apr 14, 2017
K163581 — Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. Apr 14, 2017
K170643 — Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics Apr 14, 2017
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