BEUDAMED
    16 results · 17ms · Sources: EU EUDAMED, US FDA

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    BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BACTISEAL®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519027·BACTISEAL® Endoscopic Ventricular Catheter

    CODMAN® BACTISEAL®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780537038·BEVC BACTISEAL® Endoscopic Ventricular Catheter...

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788230870·13mm - Trial Distractor, 18 Deg

    BACTISEAL

    FDA UDI
    Cerenovus, Inc.·10886704072676·BEVC BACTISEAL Endoscopic Ventricular Catheter ...

    GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BACT ENDO VENT CATH

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF·Product code JXG·January 16, 2015

    S8 COMPACT - AMERICAS

    FDA Adverse Event
    Malfunction ·RESMED LTD.·Product code BZD·January 20, 2014

    ESTEEM STRETCHY NITRILE MICROTEXTURED CHEMO TESTED

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code FMC·November 1, 2012

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 1, 2010

    Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 30, 2020

    Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·December 14, 2020

    Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 30, 2020

    Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·December 14, 2020

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018