BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    EBI ESL SPINE SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mini Master Series Bracket

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746070761·1 PAT SETUP MINI MS ROTH 022 U/L 7X7 IFIT W/HK ...

    ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO AUTOJECT MINI

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAMILON POWDER

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI200404820·NAMILON POWDER 4 OZ SHADE 82

    PYROPLAST POWDER

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI100404820·PYROPLAST POWDER 4 OZ SHADE 82

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·March 13, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA - CK - E. CHINA·Product code ITJ·August 27, 2014

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON- IRVINE TECHNOLOGY CENTER·Product code HQC·May 9, 2008

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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