BEUDAMED
    10 results · 18ms · 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.

    BONESOURCE HYDROXYAPATITE CEMENT (HAC)

    FDA 510(k)
    FDA Class 2 ·Neurology

    LPI ML210 HOLMIUM SURGICAL LASER

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

    40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 29, 2014

    CORTSCR Ø4.5 SELF-TAP L26 TI

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HWC·June 6, 2013

    4.5MM CORTEX SCREW SELF-TAPPING 30MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 6, 2018

    CORTSCR Ø4.5 SELF-TAP L38 SST

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 6, 2018

    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