BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Hypotension Decision Assist Model HDA-OR2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331194887·new orleans needle holder, 7-1/8" (18.0 cm)

    BBL GRAM IODINE

    FDA Adverse Event
    Other ·BD DIAGNOSTIC SYSTEMS·Product code KPA·February 6, 2006

    TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER

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

    ROK

    FDA 510(k)
    FDA Class 2 ·Dental

    OVERJET CARIES ASSIST

    FDA Adverse Event
    Malfunction ·OVERJET·Product code MYN·February 18, 2025

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN·Product code OUT·January 14, 2015

    APEX¿

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM ITALY S.P.A.·Product code KPE·April 6, 2026

    ENDOPATH

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code GDW·October 23, 2008

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·August 16, 2011

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code DTB·July 9, 2013

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023