BEUDAMED
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    Luja Coudé

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517302830·CoRoent XL-K Keel Cutter, 16mm Short

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154274765·BONE ANCHOR SCREWS,SELF-TAPPING

    Kleiner KG2 system

    FDA UDI
    Baat Medical Products B.V.·08720246783018·Trial

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046512098·Rotary FG gold diamond instrument for dental ap...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011251116200·ceraMotion® Ti Dentin Modifier Fluo yellow, 20 ...

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046512081·Rotary FG gold diamond instrument for dental ap...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523134229·Tesera ST, 25mm X 11mm X 16mm, Convex, T3

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523149391·Straight Implant Trial 25mm x 11mm x 16mm

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 20, 2002

    CapLOX II/TowerLOX Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL TL-560 POWER SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2025

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·November 5, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 16, 2011

    ELLIPS FX PHACO HANDPIECE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQC·July 29, 2013

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 25, 2024

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012