510(k) Clearances in 2017 — Page 43

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 43 of 64)
510(k) clearancesDetails
K163250 — Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V. May 11, 2017
K170491 — Solana C. difficile AssayQuidel Corporation May 11, 2017
K171085 — GMR40Neurologica Corporation, A Subsidiary OF May 11, 2017
K163476 — LubricityYou First Services, Incorporated May 10, 2017
K170650 — Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl May 10, 2017
K170594 — I.B.S. osteosynthesis screwsIn2Bones Sas May 10, 2017
K171080 — ALP IFCC Gen.2Roche Diagnostics Operations (Rdo) May 10, 2017
K162125 — MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. May 10, 2017
K171097 — MOJAVE Expandable Interbody SystemK2M, Inc. May 10, 2017
K162348 — ABCcolla Collagen MatrixAcro Biomedical Co., Ltd. May 10, 2017
K171081 — Guider Catheter IntroducerRhythm Xience, Inc. (Rxi) May 9, 2017
K171022 — Ablation ConfirmationNeuwave Medical, Inc. May 9, 2017
K163382 — Oxitone 1000Oxitone Medical , Ltd. May 9, 2017
K170831 — EpiAccess SystemEpiep, Inc. May 9, 2017
K171096 — Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. May 9, 2017
K163606 — Digital Blood Pressure Monitor-Automatic Upper Arm StyleShenzhen Combei Technology Co., Ltd. May 9, 2017
K162131 — ExSpiron 1XiRespiratory Motion, Inc. May 9, 2017
K170342 — Ocata Anterior Cervical SystemKalitec Direct, LLC May 9, 2017
K170393 — Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)Zibo Chengxun Automatic Device Co., Ltd. May 9, 2017
K163117 — Alpha PureKoroad America May 9, 2017
K170469 — NxStage System One PlusNxstage Medical, Inc. May 9, 2017
K170363 — Ceribell Pocket EEG DeviceCeribell, Inc. May 8, 2017
K170111 — Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC May 8, 2017
K151562 — Resultz Lice & Egg Removal KitPiedmont Pharmaceuticals, LLC May 8, 2017
K170771 — VariAx 2 Foot SystemStryker GmbH May 8, 2017
K161938 — Fingertip Pulse OximeterXuzhou Yongkang Electronic Science Technology Co., Ltd. May 8, 2017
K163327 — Precifit Medical Kirschner WiresPrecifit Medical, Ltd. May 8, 2017
K163670 — Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc. May 8, 2017
K170734 — Venus Silk.expertCyden Limited May 8, 2017
K170744 — Adhesive ElectrodesReno Medical , Ltd. May 8, 2017
K170740 — GORE VIABIL Short Wire Biliary EndoprosthesisW. L. Gore & Associates, Inc. May 8, 2017
K162594 — Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC May 8, 2017
K171094 — Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C May 8, 2017
K170180 — Will3DHdx Will Corp. May 8, 2017
K162734 — CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. May 8, 2017
K170152 — POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)Hartalega Sdn Bhd May 5, 2017
K163370 — ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEPhadia AB May 5, 2017
K170068 — Softcure 96Wellray Medical Laser, Inc. May 5, 2017
K170576 — LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. May 5, 2017
K163665 — MATRx plusZephyr Sleep Technologies May 5, 2017
K163204 — A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd. May 5, 2017
K171076 — Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. May 5, 2017
K160950 — MINISCAVSedation Systems, LLC May 5, 2017
K171082 — Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation SystemOrthofix, Inc. May 5, 2017
K162449 — Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. May 5, 2017
DEN160033 — ARK Voriconazole II Assay Test SystemArk Diagnostics, Inc. May 5, 2017
K163070 — Kent CameraKent Imaging, Inc. May 5, 2017
K163293 — Colink™ Plating SystemIn2Bones USA, LLC May 5, 2017
K170789 — In ReachCurvebeam, LLC May 5, 2017
K170475 — SICAGE™ SystemSicage, LLC May 5, 2017
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