BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049361·K-Wires, Double diamond, .035-inch (.9mm) diame...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292985·

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012740·K-Wires, Double diamond, .035-inch (.9mm) diame...

    ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    D'Vill Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DRE·February 6, 2013

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 31, 2014

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·January 26, 2011

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

    VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

    BD TRUCOUNT¿ TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 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