BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    HEMAGEN ENA [JO-1] KIT (EIA METHOD)

    FDA 510(k)
    FDA Class 2 ·Immunology

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902379628·SPACER 8915420 20MM ADD ON LORDOTIC SM

    HISTOFREEZER

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

    BIOCLONE'S ELEGANCE HCG ELISA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TAPERLOC POR LAT FMRL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 22, 2017

    M2A MODULAR HEAD COMPONENT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 8, 2017

    2008K2 HEMODIALYSIS MACHINE

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 5, 2014

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·January 9, 2013

    CAPIO SUTURE, TC-43 2N 48"

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code MFJ·November 5, 2010

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HRS·July 27, 2015

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023