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

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    LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Oticon

    FDA UDI
    Oticon A/S·05707131256256·NERA PRO, MINIBTE 312 WL 85 CNB

    980 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

    VASCUPUNCTURE PICC GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMISTEM C FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·October 31, 2013

    SMALL PERIPHERAL CUTTING BALLOON?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·October 1, 2014

    UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·May 29, 2013

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    KIDS OXYGENATOR D101

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025

    AMISTEM C, CEMENTED STEM SIZE 0 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·January 13, 2017

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015