BEUDAMED
    8 results · 34ms · 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.

    MODEL 4800 ACCUPACE PACING SYSTEM ANALYER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SKIN MARKER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TB SUSCEPTIBILITY QUADS I AND II

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 18, 2014

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·January 17, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DYB·December 14, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021