BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    REACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AMARA

    FDA UDI
    Respironics, Inc.·00606959014978·AMARA MASK WITH RS FRAME AND RS HEADGEAR, INTER...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027919·

    SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM

    FDA 510(k)
    FDA Class 2 ·Radiology

    IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    SOCLEAN2

    FDA Adverse Event
    Injury ·SOCLEAN, INC.·Product code LRJ·November 10, 2021

    FORTIFY ST VR, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 16, 2011

    CONFIDA BRECKER CURVE GUIDEWIRE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DQX·June 5, 2025

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024