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

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    KOROT Blood Pressure Monitor (KOROT P3 Accurate)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sparkle Teen Spirit Toothbrush

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063755918·Sparkle Teen Spirit Toothbrush, older youths an...

    Hohmann Lever – Curved – Very Broad

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215076641·

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250091200·ceraMotion® Zr Gingival 2, 20 g / dental cerami...

    TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Versatex Monofilament Mesh

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

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 25, 2025

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    HOTWIRE¿ RF GUIDEWIRE

    FDA Adverse Event
    Malfunction ·ATRAVERSE MEDICAL·Product code DXF·March 25, 2025

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 12, 2026

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013