BEUDAMED
    14 results · 35ms · Sources: EU EUDAMED, US FDA

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    Secret MAX Multi-platform RF System

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

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464055784·OTICON MORE 3 MINIRITE R C093 DEMO

    CMD 24-1157 PROMADE ELBOW

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDC·March 24, 2025

    BONDEASE TOPICAL SKIN ADHESIVE

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

    MODIFICATION TO SMALL BONE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT ULTRAMINI METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·June 11, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    CMD 24-1157 PROMADE ELBOW

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDC·April 2, 2026

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM NON US

    FDA Adverse Event
    Injury ·COSTA RICA·Product code LTI·November 19, 2008

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 9, 2011

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020