BEUDAMED
    15 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.

    TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A

    FDA 510(k)
    FDA Class 1 ·Microbiology

    WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

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

    DISPOSABLE YANKAUER SUCTION TUBE

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

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 22, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 4, 2014

    BD BBL MGIT PANTA ANTIBIOTIC MIXTURE, LYOPHILIZED

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·February 4, 2021

    BD BBL¿ MGIT¿ OADC ENRICHMENT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·May 13, 2024

    BD BBL¿ MGIT¿ OADC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·June 3, 2025

    BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·July 2, 2025

    BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·June 7, 2024

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·February 29, 2024

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·February 23, 2024

    BD BBL¿ MGIT¿ OADC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·February 10, 2025

    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