BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    Evanesce™ Nano-Enhanced Universal Restorative Single Dose Sample Pack HS

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172011976·Dental Composite Resin

    Athena GTX Device Management Suite (ADMS) Software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARESCAPE V100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONSULT HCG TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 21, 2013

    CE INTERMATE SV 200, 48 PACK,50125

    FDA Adverse Event
    Malfunction ·Product code FRN·January 28, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 1, 2014

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024