BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tecomet

    FDA UDI
    TECOMET INC.·00841435108318·VAMPIRE SUTURE GRASPER

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756972888·MINOR PACK

    V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 8, 2021

    CURE CATHETER HYDROPHILIC COATED

    FDA Adverse Event
    Injury ·CURE MEDICAL LLC·Product code EZD·June 4, 2020

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 10, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2014

    INDIGO SYSTEM SEPARATOR 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024