BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Neurology

    M.U.S.T. PEDICLE SCREWS SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025

    JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS

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

    EL CAPITAN Anterior Lumbar Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·January 13, 2026

    M.U.S.T. PEDICLE SCREWS SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025

    BD NEXIVA SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 10, 2024

    BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 18, 2024

    EXTRACTOR RX RETRIEVAL BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FGE·November 4, 2008

    ASR XL TAP SLV ADAP 12/14+2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011

    MEDI-LIFT

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH MAGOG INC·Product code FSA·July 11, 2013

    BD NEXIVA SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 6, 2024

    M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OUR·October 16, 2024

    BD CATHETER IV PASSIVE SAFETY NON-WINGED CLOSED SYSTEM SINGE PORT NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 28, 2024

    AMPLATZER PFO OCCLUDER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL CATD·Product code MLV·November 26, 2019

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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