BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADHERENT VISUAL STIMULATOR GOGGLES

    FDA 510(k)
    FDA Class 2 ·Neurology

    UROVYSION BLADDER CANCER RECURRENCE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 22, 2008

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    FDA Adverse Event
    Injury ·CARDINAL HEALTH·Product code HFX·August 10, 2011

    ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code OTN·July 3, 2013

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 2026

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019