BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARMONE-SCHWARZER EEG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE

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

    ACTIVA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·April 2, 2012

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 13, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 20, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 20, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 2, 2013

    TOTAL ASR FEM IMP SIZE 55

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·September 15, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATIVE CENTER-SILICON VALLEY·Product code GEX·April 26, 2011

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 21, 2013

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022