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

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    Rotatable Connector (5944RL)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464058884·OTICON ZIRCON 1 MINIRITE T C063 DEMO

    MEDI-PUMP ASPIRATOR, MODEL 1615

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

    QUENTRY DOSE REVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    SOLERA 4.75 PERCUTANEOUS RODS

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·February 8, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    LAMITRODE S-SERIES, S8, 60 CM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 17, 2011

    NONE

    FDA Adverse Event
    Other ·KOSCHER & WUERTZ GMBH·Product code GCJ·November 28, 2006

    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