BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    ALERT BED ALARM SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ORTHO

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750007479·T.CRUZI ELISA Test System 2400T

    GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    IITREL 3

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., MED REL·Product code LGW·November 12, 2010

    LFII CHAIR MOUNTED LIGHT

    FDA Adverse Event
    Malfunction ·PELTON & CRANE·Product code EAZ·February 20, 2014

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·November 8, 2012

    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