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

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    LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Truliant

    FDA UDI
    Exactech, Inc.·10885862605665·

    ABSOLUTE HCG PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 26, 2016

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 8, 2013

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 21, 2011

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FSA·August 27, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 16, 2017

    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·September 12, 2016

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018