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

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    HeRO Symphony, HeRO ES, HeRO solo/duet

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER

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

    HEARTWAY POWER MOBILITY SCOOTER, PF7

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 14, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 19, 2023

    PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code GEA·November 5, 2020

    PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code GEA·March 6, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·September 3, 2021

    NC TREK

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code DQX·October 9, 2014

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 20, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 27, 2011

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·August 20, 2021

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024