BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    NONREBREATHING VALVE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PROGREAT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·December 17, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·December 21, 2012

    PROGREAT

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQO·March 5, 2024

    TERUMO PROGREAT CATHETER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQO·February 6, 2023

    PROGREAT CATHETER

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQO·January 6, 2024

    PROGREAT

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 15, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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