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

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    AMPHETAMINE/METHAMPHETAMINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIOMET BI-POLAR SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013

    ST. JOSEPH HSP BALTIMORE MD1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 18, 2008

    AUTOPULSE LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 4, 2011

    TUNNELER, DISPOSABLE

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code DYB·March 12, 2008

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020

    CHILDRENS MERCY KS CITY MO1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

    SMART, PERFUSION PACKS, CONNECTORS, TUBING

    FDA Adverse Event
    Malfunction ·LIVANOVA USA·Product code DWE·August 1, 2023

    CSC14 CARDIOLOGIA HEAT EXCHANGER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTR·March 10, 2016

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTR·November 20, 2015

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019

    CHILDRENS MERCY KS CITY MO1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

    Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012