BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    SMR Modular Glenoid

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550216·GENUMEDI PT KNEE SUP SILVER R EW VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814299·GENUMEDI PT SILVER R VI

    HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMITH & NEPHEW SMF HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 18, 2026

    FUJIFILM BALLOON BS-4

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDA·January 14, 2021

    IDENTITY ADX XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    PINNACLE SECTOR II CUP 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 3, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 28, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021