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

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    MASC Surgical Mask

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

    SPI VARIO ANGLED ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 21, 2016

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 20, 2018

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·January 24, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 10, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2013

    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IZL·January 20, 2016

    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code LLZ·December 22, 2016

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021