BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    MILEX KEGEL PERINEAL EXERCISER

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

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981144678·Modular Trial 20x15x10mm, 10 Deg Lordosis, w/ D...

    CLEARFIL ESTHETIC CEMENT & DC BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    TIPCAM 1S 3D System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·November 27, 2024

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·February 4, 2026

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 10, 2014

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·December 10, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 23, 2015

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·March 13, 2025

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXE·September 5, 2025

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·February 11, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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