510(k) Clearances in 2017 — Page 56

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 56 of 64)
510(k) clearancesDetails
K163032 — Kyphon Xpede Bone CementMedtronic, Inc. Feb 27, 2017
K161579 — Watch-PAT200UItamar Medical , Ltd. Feb 24, 2017
K162888 — CerconDentsply Sirona Feb 24, 2017
K161372 — The Red Head Collection Device, The Jordy Connection SystemMiami Fat Supply Feb 24, 2017
K162073 — Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH Feb 24, 2017
K163480 — Renamel NANO +plusCosmedent, Inc. Feb 24, 2017
K170257 — Sydney IVF Culture OilWilliam A. Cook Australia Pty. , Ltd. Feb 24, 2017
K170218 — Vesco Medical NRFit Tip SyringesVesco Medical, LLC Feb 24, 2017
K161371 — Sonoma Fifth Metatarsal Repair SystemSonoma Orthopedic Products, Inc. Feb 24, 2017
K163513 — Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary Of Teleflex, Inc.) Feb 24, 2017
K162771 — EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. Feb 24, 2017
K161860 — TG-970P CO2 Sensor KitNihon Kohden Corporation Feb 24, 2017
K162752 — ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation Feb 24, 2017
K163056 — Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC Feb 24, 2017
K162393 — The ViewRay (MRIdian) Linac SystemViewray, Incorporated Feb 24, 2017
K160857 — HF 718BD X-Ray SystemArquilla, Inc. Dba X-Cel X-Ray Corporation Feb 24, 2017
K162916 — 3NT endoscopy system3Nt Medical , Ltd. Feb 24, 2017
K162989 — Rusch Simplastic Foley CathetersTeleflexmedical, Inc. Feb 24, 2017
K160358 — DT-100Mediana Co., Ltd. Feb 24, 2017
K161859 — MagnetOsXpand Biotechnology BV Feb 24, 2017
K161484 — ZIIP DeviceZiip,Llc Feb 24, 2017
K162071 — IllumiFlow Laser CapEglobal, LLC Feb 24, 2017
K163688 — Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC Feb 23, 2017
K161693 — Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions Feb 23, 2017
K162926 — Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH Feb 23, 2017
K160837 — MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAMMedinet Srl Feb 23, 2017
K162922 — GalaFORM 3DTepha, Inc. Feb 23, 2017
K170209 — ImPACTImpact Applications, Inc. Feb 23, 2017
K163168 — Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)Hebei Hongtai Plastic Products Company Limited Feb 23, 2017
DEN160032 — Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics Feb 23, 2017
K162827 — VIDAS B.R.A.H.M.S. PCT (PCT)bioMerieux, Inc. Feb 23, 2017
K162855 — Reveal LINQMedtronic, Inc. Feb 23, 2017
K162484 — Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. Feb 23, 2017
K161335 — Dual Top Screw SystemJeil Medical Corporation Feb 23, 2017
K163322 — TZ SKULL PIN AdultTz Medical, Inc. Feb 23, 2017
K162670 — RSM 1824C with RConsole1DRTECH Corporation Feb 23, 2017
K161316 — George King Coumadin PlasmaGeorge King Bio-Medical, Inc. Feb 23, 2017
K161907 — Pressure Therapy SystemXiamen Senyang Co., Ltd. Feb 23, 2017
K161099 — Powder Free Nitrile Examination Gloves, BlackPt. Maja Agung Latexindo Feb 23, 2017
K162937 — Stryker OrthoMap Versatile Hip SystemStryker Corporation Feb 23, 2017
K170265 — GRAVITYTM PEEK-OPTIMA Suture AnchorWrightmedicaltechnologyinc Feb 23, 2017
K161848 — Family of Steam sterilizers B17 B22 SeriesCefla S.C. Feb 23, 2017
K161607 — VISULUXCarl Zeiss Meditec, AG Feb 23, 2017
K170240 — Truliant Femoral ComponentsExactech, Inc. Feb 23, 2017
K163279 — Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. Feb 23, 2017
K162795 — PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc Feb 22, 2017
K163691 — HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Feb 22, 2017
K161926 — ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd. Feb 22, 2017
K161500 — MEG-TORQMicro-Nx Co., Ltd. Feb 22, 2017
K162800 — BLUEPRINT Patient Specific InstrumentationTornier S.A.S. Feb 22, 2017
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