BEUDAMED
    9 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.
    Filters Regulation: Us FDA ×

    EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GOT ISOENZYME ASSAY EIKEN KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSB·July 17, 2012

    12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·July 20, 2017

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 18, 2014

    SMARTSITE EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·October 21, 2010

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 20, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017