BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    MagnetOs Easypack Putty

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NeoFuse Ti3D PLIF/TLIF

    FDA UDI
    XENIX MEDICAL LLC·00818345021648·Ti3D CAGE 24L x 12W x 12H

    NeoFuse HA Enhanced PLIF/TLIF

    FDA UDI
    XENIX MEDICAL LLC·00818345020566·HA CAGE 24L x 12W x 12H

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946029661·X SERIES ADVANCED, 12 LEAD W/INTERP, PACE, SPO2...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946062392·X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LE...

    Sure Comfort

    FDA UDI
    ALLISON MEDICAL, INC.·00786227121253·31G x 3/16" (5mm) Single use disposable pen nee...

    HUDSON RCI

    FDA UDI
    TELEFLEX INCORPORATED·14026704343970·Comfort Flo Plus Cannula with Chin Strap

    HUDSON RCI

    FDA UDI
    TELEFLEX INCORPORATED·14026704743619·Comfort Flo Plus Cannula with Chin Strap

    Voyant Open Fusion Device

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

    HOUVA 3 PHOTOTHERAPY SYSTEM

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

    Cook

    FDA UDI
    COOK INCORPORATED·00827002462281·Cook, Cutting Loop 24FR, .012" Wire, 12 Degrees

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code NKB·September 9, 2011

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·July 22, 2013

    Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).

    FDA Enforcement
    Class III ·Terminated·Stryker Instruments Div. of Stryker Corporation·February 18, 2015

    COOK CUTTING LOOP

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEI·November 9, 2017

    COOK CUTTING LOOP

    FDA Adverse Event
    Injury ·COOK INC·Product code GEI·November 10, 2017

    ASMUTH

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·August 6, 2025

    Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·December 22, 2014

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014