BEUDAMED
    7 results · 21ms · 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.

    IRISPEC URINE CHEMISTRY CONTROL PART A AND B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCESS(R) FREE T4 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HOWMEDICA SENTRY S TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·February 6, 2013

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 28, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020