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

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    OB-PH - PH TEST PAPER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515148765·Kreidler Periosteal Elevator, 6mm tip 7 1/4", S...

    FETAL HEART DETECTOR #'S D102 & D102R

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    NX3

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·June 5, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code FTL·November 29, 2012

    UNKNOWN DEPUY INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·September 28, 2010

    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