BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    ProSeal™ Injection Site Extended Male Luer Lock (422140)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257141977·30-40 MFW VITALITY CALF CT CHARC III

    AGILITY

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295122241·AGILITY LP +1 POLY TRIAL SIZE 3

    AGILITY

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295122258·AGILITY LP POLY TRIAL SIZE 3/2

    AGILITY

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295122234·AGILITY LP TIB INSERT TRIAL SIZE 3

    SINON

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

    iBalance UKA Tibial Tray Implant

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    ISOFLEX S

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·July 22, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    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