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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Konicaminolta DI-X1

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ceramco® II Silver™

    FDA UDI
    Dentsply International Inc.·D0011824310·

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DIGITAL ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 22, 2015

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 19, 2012

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 2, 2015

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 31, 2012

    AIR OPTIX AQUA

    FDA Adverse Event
    Injury ·CIBA VISION JOHORE SDN.BHD·Product code LPM·July 22, 2011

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020

    URETERAL BRUSH BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FDX·November 15, 2023

    THERMAGE CPT SYSTEM TIP

    FDA Adverse Event
    Injury ·SOLTA MEDICAL INC·Product code GEI·November 30, 2022

    URETERAL BRUSH BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FDX·January 7, 2022

    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