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

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    Swoop Portable MR Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    BENCO VALULINE

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975003263·VALULINE VPS HANDMIX PUTTY FS

    JDEVOLUTION PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 6, 2025

    Elecsys HSV-1 IgG (08948844160)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INRATIO SELF-TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    1221923-2002-00001

    FDA Adverse Event
    Other ·Product code HIF·February 6, 2002

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 1, 2011

    ENDO GIA ROTICULATOR 60-2.5 SULU

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·November 4, 2008

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·August 17, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 5, 2013

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·February 14, 2013

    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