BEUDAMED
    13 results · 34ms · Sources: EU EUDAMED, US FDA

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    AMERIMED AS110

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWER SUPPLY / BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code IYN·March 28, 2011

    POWER SUPPLY/BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code ITX·July 30, 2010

    POWER SUPPLY/BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code ITX·June 25, 2010

    Edwards Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    DASHER -14 STEERABLE GUIDEWIRE

    FDA Adverse Event
    Injury ·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP·Product code DQX·January 9, 2007

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·February 9, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·January 7, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2014

    11MM/130 DEG TI CANN TFNA 170MM - STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·March 17, 2017

    TFNA HELICAL BLADE 115MM STERILE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·February 23, 2017

    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