BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    TCM400

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LINER: MPACT FLAT PE HC LINER Ø32/C

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 19, 2022

    CD HORIZON ECLIPSE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRA V THERAPEUTIC ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PTERYFIT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 26, 2026

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 12, 2013

    EXPRO ELITE SNARE

    FDA Adverse Event
    Malfunction ·AV-RADIUS·Product code MMX·February 25, 2011

    BIOKNOTLESS ANCHORS

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MBI·February 25, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016