BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR

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

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209104536·

    FEATHER-FLEX ADULT ANESTHESIA CIRCUIT

    FDA Adverse Event
    Malfunction ·BOMIMED INC.·Product code BSJ·August 28, 2014

    REMOTE CARE MANAGEMENT SYSTEMS (RCMS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency

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

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 5, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 29, 2012

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 29, 2010

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021