510(k) Clearances in 2017 — Page 55

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 55 of 64)
510(k) clearancesDetails
K170167 — True 3D Viewer SoftwareEchopixel, Inc. Mar 3, 2017
K162524 — AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc. Mar 3, 2017
K162044 — Dentca Denture Base IIDentca, Inc. Mar 3, 2017
K160345 — Glass Ionomer CementShandong Huge Dental Material Corporation Mar 3, 2017
K162947 — Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular StaplerChongqing Qmi Surgical Co., Ltd. Mar 3, 2017
K162580 — Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. Mar 3, 2017
K163528 — HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. Mar 3, 2017
K170314 — ACL AcuStarInstrumentation Laboratory CO Mar 3, 2017
K161304 — EndoPur FilterNephros, Inc. Mar 2, 2017
K161430 — Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited Mar 2, 2017
K162811 — MR Conditional CGA 870Essex Industries, Inc. Mar 2, 2017
K162356 — Vesair Cystoscopic SheathSolace Therapeutics Mar 2, 2017
K170355 — RayStation 6RaySearch Laboratories AB (PUBL) Mar 2, 2017
K153688 — Edi Catheter ENFitMaquet Critical Care AB Mar 2, 2017
K170348 — Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien Mar 2, 2017
K162199 — Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. Mar 2, 2017
K161892 — Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd. Mar 2, 2017
K163497 — EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture BoltEncore Medical L.P. Mar 2, 2017
K161554 — ENDOFLATOR 40, ENDOFLATOR 50KARL STORZ Endoscopy-America, Inc. Mar 2, 2017
K161737 — RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX UndyedMyco Medical Mar 2, 2017
K161633 — REXLON, REXSILSm Eng Co., Ltd. Mar 2, 2017
K162364 — Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. Mar 2, 2017
K162410 — TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. Mar 2, 2017
K153538 — Dextramer CMV KitImmudex Aps Mar 2, 2017
K170420 — n!ce Glass Ceramic Blocks for Amann GirrbachInstitut Straumann AG Mar 2, 2017
K163379 — KneeAlign 2 SystemOrthalign, Inc. Mar 2, 2017
K163284 — syngo. CT Neuro PerfusionSiemens Medical Solutions USA, Inc. Mar 1, 2017
K162026 — EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem ExtensionsMicroport Orthopedics, Inc. Mar 1, 2017
K170332 — DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESSCanon, Inc. Mar 1, 2017
K162383 — Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. Mar 1, 2017
K170008 — Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle SetCook Incorporated Feb 28, 2017
K163709 — FIRMap CatheterAbbott Electrophysiology Feb 28, 2017
K162837 — Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser SystemLumenis, Ltd. Feb 28, 2017
K163282 — Apex Dental SensorsMasterlink, LLC Feb 28, 2017
K162753 — RTC 26-C Inline Aerosol AdapterInstrumentation Industries, Inc. Feb 28, 2017
K163543 — Biomet Fusion SystemZimmer Biomet Spine, Inc. Feb 28, 2017
K163008 — CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc. Feb 28, 2017
K170283 — BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson And Company Feb 28, 2017
K170105 — Jac-Cell Medic testersJac-Cell Medic Feb 28, 2017
K163234 — Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc. Feb 28, 2017
K162018 — Surface Applicator SetVarian Medical Systems, Inc. Feb 28, 2017
K163038 — EPIC Extremity Snap-Off ScrewEpic Extremity, LLC Feb 28, 2017
K161655 — On1 ConceptNobel Biocare AB Feb 28, 2017
K163245 — Virtual Occupational Therapy Application (VOTA)Barron Associates, Inc. Feb 28, 2017
K163591 — BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson And Company Feb 27, 2017
K162982 — Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)Medline Industries, Inc. Feb 27, 2017
K170373 — Flextra Steerable IntroducerRhythm Xience, Inc. (Rxi) Feb 27, 2017
K161853 — proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt SystemAesculap, Inc. Feb 27, 2017
K163191 — ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd. Feb 27, 2017
K162903 — Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc. Feb 27, 2017
← Previous Page 55 of 64 Next →