BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    LISA Laser Surgical Fibers

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EXEL BUTTERFLY SCALP VEIN SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BONETRAP

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

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 23, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·November 3, 2014

    RIATA ST PASSIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·August 30, 2022

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021