BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    SHUR-LOCK ICE WRAP SYSTEM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MOR Comfort Cap 4 pack

    FDA UDI
    STERNGOLD DENTAL LLC·00841549119170·The MOR® Comfort Caps are used after MOR® mini ...

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 5, 2024

    MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BLOOD GAS CALIBRATION STANDARD

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYRINGE ADAPTOR SET

    FDA Adverse Event
    Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·November 22, 2010

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 9, 2013

    TX1 TISSUE REMOVAL SYSTEM - MOCROTIP

    FDA Adverse Event
    Malfunction ·TENEX HEALTH·Product code LFL·May 19, 2014

    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