BEUDAMED
    9 results · 21ms · 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.
    Filters Regulation: Us FDA ×

    DEKA TORO

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

    Shannon Recta Larga Round Shank

    FDA UDI
    Gebr. Brasseler GmbH & Co. KG·14053613289600·

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464057474·SONIC RADIANT 20 MNR T GR/DG

    DB-Orthopedics

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DOSI-FUSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNIFY ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 10, 2014

    UNIFLEX 29MM

    FDA Adverse Event
    Malfunction ·ROCHESTER MEDICAL CORPORATION·Product code KOD·September 2, 2011

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 22, 2013

    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