BEUDAMED
    14 results · 20ms · 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.

    CT Cardiomegaly

    FDA 510(k)
    FDA Class 2 ·Radiology

    SONILASE LIGHT THERAPY DEVICE

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

    TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KDQ·August 26, 2011

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·September 11, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 18, 2013

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·January 11, 2019

    GNS II NON-POR TIB SZ 7 RIGHT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 18, 2019

    GEN II RESURF PATELLA 38MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 19, 2019

    LEGION CR NP FEM SZ 8 RT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 18, 2019

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Tenex Health Inc·May 14, 2014

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·July 3, 2024