BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    Facet Aurora Reusable Lancet Base

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARIX Ankle Distal Tibia System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REST ASSURED, GEN II ORIGINAL

    FDA Adverse Event
    Malfunction ·RANIR, LLC·Product code OBR·November 6, 2014

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 22, 2011

    SURESTREAM INTRASPINAL CAT KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code LMP·July 18, 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