BEUDAMED
    18 results · 38ms · Sources: EU EUDAMED, US FDA

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    LAGUNA SOFTIP DIAGNOSTIC CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VertiForm Posterior Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSFERION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CDS/R/4K DILUENT/SHEATH, 20L

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIV/CELLDYN·Product code GKL·April 12, 2007

    CD SAPPHIRE, CD 4000 SYSTEMS DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIV/CELLDYN·Product code GKL·December 8, 2006

    CELL-DYN DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·February 14, 2013

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·January 10, 2011

    MICRUSPHERE 10 - PLATINUM MICROCOIL

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·July 28, 2014

    FT3 - FREE TRIIODOTHYRONINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·July 21, 2014

    TSH, THYROTROPIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·May 20, 2014

    FT3 - FREE TRIIODOTHYRONINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·April 30, 2014

    TSH, THYROTROPIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·April 9, 2014

    TSH, THYROTROPIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·March 24, 2014

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

    FT4, FREE THYROXINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025