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

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    ZERONA

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

    AF541

    FDA UDI
    Respironics, Inc.·00606959046696·AF541 Under the Nose Mask, with Standard Elbow,...

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828137317·GEN4 Direct Access

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828106665·GEN4 Direct Access

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828156325·GEN4 INTERACTIVE

    DYNACOR LUBRICATION GEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code LFL·June 9, 2011

    COOK® MULTI-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·May 10, 2019

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 21, 2020

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·August 19, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 15, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·December 10, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·November 4, 2022

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·March 3, 2020

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 13, 2020

    Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

    FDA Enforcement
    Class II ·Ongoing·Gentell, Inc·May 13, 2020