510(k) Clearances in 2017 — Page 37

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 37 of 64)
510(k) clearancesDetails
K170747 — syngo Application SoftwareSiemens Medical Solutions USA, Inc. Jun 9, 2017
K170996 — Wingman 14C Crossing CatheterReflow Medical, Inc. Jun 9, 2017
K171420 — 1717SCC_127um and 1717SCC_140umRayence Co., Ltd. Jun 9, 2017
K170792 — Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. Jun 9, 2017
K162569 — YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal MoisturizerBiotech Lubricants, Ltd. Jun 9, 2017
K170169 — PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. Jun 9, 2017
K170762 — Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC Jun 9, 2017
K163636 — ePlex Respiratory Pathogen PanelGenmark Diagnostics, Incorporated Jun 9, 2017
K163313 — ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc. Jun 9, 2017
K170515 — Sterile Nitrile Surgical Gloves, Powder-freePrimus Gloves Pvt Limited Jun 9, 2017
K161883 — CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. Jun 9, 2017
K162685 — 2-Piece Hammertoe Correction SystemLife Spine, Inc. Jun 9, 2017
K171419 — 1717SGC_127um and 1717SGC_140umRayence Co., Ltd. Jun 9, 2017
K163475 — iVueOptovue, Inc. Jun 9, 2017
K170730 — JAZZ System, including JAZZ BandImplanet, S.A. Jun 9, 2017
K171086 — Accuray Precision Treatment Planning SystemAccuray Incorporated Jun 8, 2017
K162610 — NEXA Negative Pressure Wound Therapy SystemNexa Medical , Ltd. Jun 8, 2017
K170101 — Valiant Curing LightInter-Med/Vista Dental Products Jun 8, 2017
K171112 — Trifore(tm) Cervical Plating SystemNeurostructures, Inc. Jun 8, 2017
K163580 — ASD Oral AppliancesAmerican Sleep Dentistry Jun 8, 2017
K170961 — NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated Jun 8, 2017
K171066 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC Jun 8, 2017
K170661 — Novosyn Quick Absorbable SutureAesculap, Inc. Jun 8, 2017
K170763 — Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc. Jun 8, 2017
K163193 — UTF Stem, reduced, #0, #00United Orthopedic Corporation Jun 8, 2017
K170366 — Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC Jun 8, 2017
K161327 — SYNTEC HUMERAL NAIL SYSTEMSyntec Scientific Corporation Jun 8, 2017
K171222 — Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation Jun 8, 2017
K170967 — Intraskan DC PlusSkanray Technologies Private Limited Jun 8, 2017
K171256 — Quingo Flyte Mobility ScooterAgile Distributors, LLC Jun 8, 2017
K162996 — INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc. Jun 8, 2017
K170821 — ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP Jun 8, 2017
K170681 — Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc. Jun 8, 2017
K170460 — Sorin ConnectSorin Group Deutschland GmbH Jun 8, 2017
K162689 — Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. Jun 8, 2017
K170728 — E. HISTOLYTICA QUIK CHEKTechlab, Inc. Jun 7, 2017
K160673 — Insulin Algorithms SystemInsulin Algorithms Jun 7, 2017
K163357 — OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division Of Cilag GmbH Jun 7, 2017
K171357 — SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner Of Tei Biosciences) Jun 7, 2017
K171088 — Cochlear Baha SoundArcCochlear Americas Jun 7, 2017
K170772 — Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mLLiofilchem S.R.L. Jun 7, 2017
K170751 — MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated Jun 7, 2017
K171335 — Venture 038 catheterVascular Solutions, Inc. Jun 7, 2017
K162109 — Kwart Retro-Inject Ureteral StentCook Incorporated Jun 7, 2017
K170356 — Straumann Variobase AbutmentsInstitut Straumann AG Jun 7, 2017
K170354 — Straumann Variobase AbutmentsInstitut Straumann AG Jun 7, 2017
K163531 — Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation Jun 7, 2017
K163679 — Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited Jun 7, 2017
K162564 — Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. Jun 7, 2017
K170736 — HySil Impression MaterialsOsstem Implant Co., Ltd. Jun 7, 2017
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