BEUDAMED
    10 results · 34ms · Sources: EU EUDAMED, US FDA

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    OCHSNER ULP BIFURCATION VASCULAR PROTHESIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMMULISA SCI-70 ANTIBODY ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    BENZODIAZEPINES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VSP SYSTEM

    FDA Adverse Event
    Injury ·3D SYSTEMS·Product code DZJ·December 18, 2020

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013

    MCGHAN STYLE

    FDA Adverse Event
    Malfunction ·ALLERGAN (INAMED AESTHETICS)·Product code FWM·November 16, 2010

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 3, 2014

    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

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015