BEUDAMED
    12 results · 30ms · Sources: EU EUDAMED, US FDA

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    SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VIDAS CEA (S) ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    OPTICAL INTEGRITY LASERGUARD FIBERS

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 7, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 22, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 6, 2020

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 6, 2020

    MICRUSFRAME18 15MM X 50CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 1, 2020

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS INC.·Product code QFG·January 22, 2026

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 4, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 29, 2008