BEUDAMED
    7 results · 23ms · 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 ×

    MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE

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

    LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION INC·Product code DRM·January 2, 2013

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·December 3, 2010

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Death ·HEARTWARE, INC·Product code DSQ·July 15, 2014

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021