BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    CPR C-SECTION DELIVERY PACK

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GLOVES, STERILE LATEX SURGEON'S

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SPEC SILTEX RND 425CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·April 21, 2025

    OCCIPITAL-PL 4.5/5 MED W/50 TI

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code KWP·February 14, 2013

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 28, 2014

    UNKNOWN

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code N/A·January 7, 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