BEUDAMED
    13 results · 34ms · Sources: EU EUDAMED, US FDA

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    Leaderflex Mini and Leaderflex Nano

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SOLARA JR. MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 29, 2002

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 29, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    8.5 Fr Introducer Set, REF 21-2370-24

    FDA Recall
    Terminated ·Deltec, Inc·Product code DYB·March 29, 2004

    UNKNOWN CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 20, 2018

    ACTIVE ARTICULATION E1 HIP BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 20, 2018

    UNKNOWN STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 20, 2018

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023