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

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    Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446929574·SPECIAL, TAPERFILL BIPOLAR TRIALS, -3.5mm OFFSE...

    Disposable Blade

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50

    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENDOSCOPIC FIBEROPTIC CABLE

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

    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.

    FDA Enforcement
    Class III ·Terminated·Coloplast Manufacturing US, LLC·November 5, 2014

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 4, 2016

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·October 20, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·Product code FRN·August 11, 2011

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD

    FDA Adverse Event
    ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 25, 2019

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 25, 2019

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 8, 2019

    TRIFECTA¿ GT VALVE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LWR·September 5, 2023

    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code NAD·September 8, 2014

    UNK - CONSTRUCTS: EXPERT FEMORAL NAIL

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code JDS·May 16, 2022

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code GEX·December 23, 2020

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·May 16, 2019

    O-ARM IMAGING SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·January 9, 2020

    O-ARM IMAGING SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·January 9, 2020