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

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    DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK CINOXACIN, 100 MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Injury ·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009

    SETROX S 60

    FDA Adverse Event
    BIOTRONIK SE & CO. KG·Product code NVN·April 16, 2013

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 16, 2011

    CELLSEARCH CIRCULATING TUMOR CELL KIT

    FDA Adverse Event
    Malfunction ·VERIDEX LLC·Product code NQI·June 16, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015