BEUDAMED
    9 results · 37ms · 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.

    VENTREX ENZYME TSH KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LEAVE ACTIVE PFC CVD 10MM SZ5

    FDA Adverse Event
    Injury ·K830927·Product code JWH·April 18, 2012

    Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WHITE KNIGHT SUPPLEMENTAL DRAPE

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

    MEDSOURCE

    FDA Adverse Event
    Malfunction ·MEDSOURCE·Product code LHI·July 18, 2017

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 23, 2014

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 13, 2012

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR -REDWOOD CITY·Product code MGB·September 7, 2010

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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