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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    D-10 Hemoglobin A1c Program

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Oticon

    FDA UDI
    Oticon A/S·05707131305244·SENSEI PRO, BTE 13 WL 90 AQM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776181314·VANDERBILT DEEP VESSEL FORCEPS . CVD SERR

    EMG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024

    UNKNOWN SAPPHIRE PUMP

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Injury ·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026

    AESCULAP SURGICAL INSTRUMENTS

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

    AESCULAP SURGICAL INSTRUMENTS

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026

    UNKNOWN SAPPHIRE PUMP

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026

    SAPPHIRE M.T INFUSION PUMP - GERMAN

    FDA Adverse Event
    Death ·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025

    6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 23, 2014

    HS III PROXIMAL SEAL SYTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR·Product code DXC·June 13, 2011

    OXF DOMED LAT MEN BRNG SZ 3 UK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·May 25, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021