BEUDAMED
    9 results · 18ms · 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.

    STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW

    FDA 510(k)
    FDA Class 2 ·Hematology

    VECTORVISION CT/FLUORO

    FDA 510(k)
    FDA Class 2 ·Neurology

    3181 DUO DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 16, 2013

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·April 1, 2011

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·June 17, 2008

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024