BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    iTotal Family Reusable Instrument Tray

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·March 20, 2020

    WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CARDIOCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    GALAXY G3 MINI 1.5MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 20, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 14, 2013

    IAB : 8 FR - 40 CC

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·September 11, 2008

    PROGREAT

    FDA Adverse Event
    Injury ·Product code DQO·April 30, 2021

    PROGREAT

    FDA Adverse Event
    Malfunction ·Product code DQO·May 28, 2021

    TERUMO PROGREAT CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 25, 2022

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·October 17, 2019

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

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