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

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    HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)

    GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·April 5, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    PERIMOUNT MAGNA EASE AORTIC SIZER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DTI·November 5, 2008

    PFC SIGMA UNI FEMORAL SZ 4

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code HRY·August 18, 2011

    SARNS CENTRIFUGAL PUMP

    FDA Adverse Event
    Other ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·July 15, 2013

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·February 14, 2018

    PELVIC REDUCTION FORCEPS

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HTD·June 7, 2016

    DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens

    FDA Enforcement
    Class II ·Ongoing·Diasorin Inc.·December 18, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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