BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    NeuroStar Advanced Therapy System (All previously cleared models)

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978948935·INSTRUMENT 8231926 7.0MM TAP

    THERMOPULSE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    ASR UNI FEMORAL IMPL SIZE 55

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011

    BONE PLATE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 6, 2014

    PROTOCO2L INSUFFLATION SYSTEM

    FDA Adverse Event
    Injury ·E-Z-EM, INC.·Product code FCX·July 11, 2013

    Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G

    FDA Enforcement
    Class II ·Ongoing·Apellis Pharmaceuticals, Inc.·October 11, 2023