BEUDAMED
    13 results · 38ms · Sources: EU EUDAMED, US FDA

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    GM501 Wash

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

    VITAPHONE. MODEL 100 BT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SRI LEVEL II SURGICAL GOWN

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

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·October 9, 2008

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 26, 2013

    SOFT TOUCH ® II

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 4, 2011

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 4MM X 7CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 15, 2022

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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