BEUDAMED
    45 results · 28ms · Sources: EU EUDAMED, US FDA

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    ADD-VANTAGE ADDAPTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ThermoCool SmartTouch

    FDA UDI
    Biosense Webster Inc·10846835009002·

    THERMOCOOL SMARTTOUCH

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC.·Product code LPB·January 29, 2021

    EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INSORB ABSORBABLE STAPLE, MODEL SP-B20

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    U-BLADE SET, TI GAMMA3 10.5X100MM

    FDA Adverse Event
    Injury ·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012

    SMARTABLATE GENERATOR KIT-WW

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code LPB·August 14, 2018

    ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 5, 2014

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 31, 2022

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·April 6, 2015

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·May 29, 2013

    ESOPHYX2 - LINK DESIGN

    FDA Adverse Event
    Injury ·REDMOND·Product code ODE·June 16, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

    SAFESEPT TRANSSEPTAL GUIDEWIRE

    FDA Adverse Event
    Injury ·PRESSURE PRODUCTS, INC.·Product code DRC·August 12, 2023

    ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·October 19, 2014

    THMCL SMARTTOUCH,TC,F,C3

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·July 11, 2018

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016

    THMCL SMARTTOUCH,TC,F,C3

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·July 10, 2018

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015

    THMCL SMARTTOUCH,TC,F,C3

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·November 29, 2017