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

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    ACTIVECARE ++ SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REMEL

    FDA UDI
    REMEL, INC.·00848838005763·Andrades Broth w/1% Mannitol 20/PK

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099662·MAX MOLAR BDS PEDO ASST 100

    TensCare

    FDA UDI
    TENSCARE LIMITED·05033435136490·The Nouri Digital Electric Breast Pump is a pow...

    ENA EIA KIT RANGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    SERRALNYL

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

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·April 11, 2013

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·June 11, 2008

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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