BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    ALK-PHOS BIOPAK GEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NTERFACE

    FDA UDI
    WINFIELD LABORATORIES INC·00858150000483·Single Sheet 12 inches X 12 inches - Box 12

    Oph.Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668119785·Folden Femto D-E Dissector, 0.7 & 1.2mm

    GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    Agile Esophageal Stent System

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

    FEMORAL CEMENT RESTRICTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 25, 2009

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 4, 2014

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·June 2, 2015

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 20, 2010

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 30, 2020

    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