BEUDAMED
    19 results · 27ms · Sources: EU EUDAMED, US FDA

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    PosiSep X BAM Hemostat Dressing/Intranasal Splint

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ambIT

    FDA UDI
    SUMMIT MEDICAL PRODUCTS, INC.·00857595005596·PreSet Pump

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180135406·3 MM DIA., 33 CM INSULATED CONE ELECTRODE, SIDE...

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776209766·Switching stick rounded tip

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306824494·Walther Female Dilator-Catheters 13cm, 26Fr

    Powder Free Nitrile Examination Glove (Aqua Green)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·September 8, 2021

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code LKK·November 4, 2008

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 23, 2011

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025