BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

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

    MIRROR SUCTION Double Sided HEAD (1)

    FDA UDI
    HAGER WORLDWIDE, INC.·00014081540768·mirror suction double sided evacuation tip head...

    MIRROR SUCTION Double Sided HEAD (1)

    FDA UDI
    HAGER WORLDWIDE, INC.·D2482540760·mirror suction double sided evacuation tip head...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154546480·COMPRESSION PLATE, ANGLED, FOR 2.0MM

    EsCem

    FDA 510(k)
    FDA Class 2 ·Dental

    iCare ALTIUS CW

    FDA 510(k)
    FDA Class 2 ·Radiology

    CURLIN PUMP 6000 CMS

    FDA Adverse Event
    Malfunction ·MOOG COSTA RICA, SRL·Product code FRN·October 26, 2022

    VITALITY EL

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 19, 2011

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code NJL·July 26, 2013

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014