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

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    ADEL MODEL 2100 BIRTHING BED

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PERRY SUTURING SET W/ANESTHETIC

    FDA 510(k)

    LASER LENS-VARIOUS MODELS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 16, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 15, 2012

    13CONSULTA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·October 19, 2010

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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