BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122949·K-WIRE - SINGLE TROCAR 1.6mm DIA x 200mm

    CHILDREN'S SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NON-PRESCRIPTION SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    UNKNOWN DEPUY POLY ACETABULAR LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·January 9, 2013

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·November 15, 2010

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    IRC2100 W/ 210 LIGHTGUIDE

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code KNS·August 28, 2019

    Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013