BEUDAMED
    10 results · 19ms · 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.

    CORNEAL LIGHT SHIELD

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

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584269·Apex Tibial Nail Ø 8.5 x 270mm

    Luja Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOMET CC CRUCIATE TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 25, 2018

    LAMITRODE TRIPOLE 16C

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 15, 2014

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 1, 2010

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·November 29, 2012

    GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 7, 2014

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015