BEUDAMED
    16 results · 32ms · Sources: EU EUDAMED, US FDA

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    ANTIMICROBIAL SUSCETIBILITY TEST PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Class B 21 CTB - Jump Bag 5210

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620039·Class B 21 CTB - Jump Bag 5210

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690126478·Adjustable Modular Tibia Tray Trial Size 3

    StaGraft DBM Putty

    FDA UDI
    Biomet Orthopedics, LLC·00880304686830·Demineralized Bone Matrix (DBM) in a Lipid Carrier

    RENEW INSERT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 9, 2012

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·January 15, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·December 8, 2010

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2014

    VANGUARD CR FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·August 10, 2017

    REGENEREX PRIMARY TIBIAL TRAY

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·August 10, 2017

    BIOMET MODULAR FINNED STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·August 10, 2017

    REGENEREX PRIMARY PATELLA

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·August 10, 2017

    VANGUARD TIBIAL BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·August 10, 2017

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025