BEUDAMED
    52 results · 23ms · Sources: EU EUDAMED, US FDA

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    DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ThermoCool SmartTouch

    FDA UDI
    Biosense Webster Inc·10846835009194·

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277100955·Cannestra Hip Length Gauge Pin 130mm

    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    EASY CUFF

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30

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

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·March 13, 2015

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    WEBSTER¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·June 15, 2012

    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

    CARTO® 3 SYSTEM INTERFACE CABLE

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DQK·March 27, 2012

    VERSAFITCUP CC HIGHCROSS PE LINER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2013

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 29, 2013