BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    FREERIDER FR1, models FR1-13, FR1-15, FR1-17

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Oticon A/S·05707131260574·RIA PRO, MINIRITE 312 WL SGR

    BD PLASTIPAK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·November 27, 2018

    INTERLAB IMMUNOFIXATION TEST(S)

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALERE CHOLESTECH LDX MULTIANLYTE CONTROLS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JJY·November 20, 2015

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code ILS·May 29, 2013

    ST104 TRANSPORT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·May 4, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·August 22, 2008

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·November 8, 2018

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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