BEUDAMED
    7 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 ×

    WESTMED CONDESATE COLLECTION TRAP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ASA BLOOD TUBING LINES

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

    CAPRI

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

    PNEUPAC PARAPAC

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL MD, INC.·Product code BTL·January 9, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2014

    UNK DEPUY GHV CEMENT

    FDA Adverse Event
    Injury ·DEPUY CMW·Product code LOD·January 5, 2011

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

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