BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    Mako Partial Knee Application

    FDA 510(k)
    FDA Class 2 ·Neurology

    Sentinel

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125782·SENTINEL 11 NETWORKED TEST SYSTEM

    SENTINEL

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129292·SENTINEL 11 NETWORKED TEST SYSTEM

    5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·October 22, 2018

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRE·October 22, 2018

    LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·June 12, 2017

    LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·January 10, 2018

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·October 16, 2018

    PLMA DVC V11.51 1 R

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 5, 2013

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008

    UNICEL DXC 600 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGA·June 24, 2011

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC.·Product code DRE·December 7, 2018

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·October 15, 2018

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·April 13, 2017

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRE·December 11, 2019

    LEAD EXTRACTION EVOLUTION SHORTIE MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·March 22, 2017

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·May 11, 2017

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021