510(k) Clearances in 2017 — Page 27

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 27 of 64)
510(k) clearancesDetails
K163446 — AxoGen Nerve CapAxogen Corporation Aug 8, 2017
K171444 — YUKON OCT Spinal SystemK2M, Inc. Aug 8, 2017
K170845 — MiniMAXMedacta International S.A. Aug 8, 2017
K171451 — Ahmed Glaucoma Valve Model FP8New World Medical, Inc. Aug 8, 2017
K171881 — JAZZ Passer BandImplanet, S.A. Aug 8, 2017
K172129 — HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Aug 8, 2017
K163390 — iC-GPC Assay TM for use on the iC-SystemTMIcubate, Inc. Aug 8, 2017
K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc. Aug 8, 2017
K171389 — EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. Aug 8, 2017
K170588 — DESS Dental Smart SolutionsTerrats Medical SL Aug 8, 2017
K170939 — Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated Aug 8, 2017
K163225 — AFIAS iFOB with AFIAS-50Immunostics Inc., Aug 8, 2017
K170888 — Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies Aug 8, 2017
K171707 — GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1AGowoonsesang Cosmetics Co., Ltd. Aug 8, 2017
K170529 — Delight, Delight ortho, B&Lite SDentall Co., Ltd. Aug 8, 2017
K170272 — TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV Aug 8, 2017
K171684 — Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources Corporation Aug 7, 2017
K170738 — InMode Diolaze XLInmode MD , Ltd. Aug 7, 2017
K171362 — Merit SyringeMerit Medical Systems, Inc. Aug 7, 2017
K171386 — dpl SpectraLiteLed Technologies, Inc. Aug 7, 2017
K170851 — Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc. Aug 7, 2017
K170038 — FuzeFix Screw SystemFusion Orthopedics, LLC Aug 7, 2017
K171712 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps Aug 7, 2017
K171366 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger KitStimwave Technologies Inc., Dba Stimq, LLC Aug 4, 2017
K160850 — Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti Aug 4, 2017
K170861 — PremierShandong Weigao Orthopaedic Device Co., Ltd. Aug 4, 2017
K163393 — Hi-Dow Wireless TENS/EMS System (Model HD-5N)Hi-Dow International, Inc. Aug 4, 2017
K171147 — REVEAL BulkBisco, Inc. Aug 4, 2017
K171596 — ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound NeedleWilson-Cook Medical, Inc. Aug 4, 2017
K163251 — Life Essence Universal Porcelain SystemBlue Sky Bio Aug 4, 2017
K172081 — Maestro MicrocatheterMerit Medical Systems, Inc. Aug 4, 2017
K171345 — Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies Aug 4, 2017
K152300 — GlucommanderGlytec, LLC Aug 4, 2017
K171322 — eCareManager 4.1Visicu, Inc. Aug 3, 2017
K171390 — dpl II PanelLed Technologies, Inc. Aug 3, 2017
K170919 — The TiBow Expandable Spacer SystemLife Spine, Inc. Aug 3, 2017
K171164 — U-Lite EXPSonoscanner Aug 3, 2017
K161358 — Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service And Savings, Inc. Aug 3, 2017
K172039 — CATHTONG II PICC CatheterL&Z Us, Inc. Aug 3, 2017
K162744 — Everyway OTC EMS, Model EV-805Everyway Medical Instrument Co., Ltd. Aug 3, 2017
K171456 — Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine Aug 3, 2017
K162507 — Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC Aug 3, 2017
K171356 — Clarity RevealCeevra, Inc. Aug 3, 2017
K170928 — CADence SystemAum Cardiovascular, Inc. Aug 3, 2017
K172036 — Medrobotics Flex Robotic SystemMedrobotics Corporation Aug 3, 2017
K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC Aug 2, 2017
K170651 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable NeedleYangzhou Medline Industry, Co., Ltd. Aug 2, 2017
K171717 — AUTOCON III 400KARL STORZ Endoscopy-America, Inc. Aug 2, 2017
K162832 — 731 Series VentilatorsZOLL Medical Corporation Aug 2, 2017
K171595 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. Aug 2, 2017
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