BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    Manual Tissue Removal Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Mirror Suction Single-Sided - Introductory Kit

    FDA UDI
    HAGER WORLDWIDE, INC.·D2482540501·mouth mirror evacuation tip kit w/ single-sided...

    Mirror Suction Single-Sided - Introductory Kit

    FDA UDI
    HAGER WORLDWIDE, INC.·00014081540508·mouth mirror evacuation tip kit w/ single-sided...

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111818·Modular Tibia Augment Size 5 x 4mm

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101216·FRANCIS FOREIGN BODY SPUD

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690131106·High Performance Revision Tibia Augment, Size 5...

    HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENT Nasopharyngoscope and Accessories

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NA

    FDA UDI
    Exactech, Inc.·10885862525475·TRIAL, TIBIAL ADAPTOR, PLATE, SIZE 5

    QUADRA R FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026

    VENTAK PRIZM 2 VR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 19, 2011

    2.7MM CORTICAL SCREW 12MM LONG

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code HRS·July 26, 2013

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Recall
    Terminated ·Omni Life Science·Product code JWH·August 9, 2012

    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