BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    EndoTool IV (3.1)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tyber Medical

    FDA UDI
    Tyber Medical, LLC·M695502P241088S1·PLIF 24mm x 8mm x 10mm x 8 °, TyPEEK, Sterile

    Tyber Medical

    FDA UDI
    Tyber Medical, LLC·M695302P241088S1·PLIF 24mm x 8mm x 10mm x 8 °, PEEK, Sterile

    PLIF Interbody System

    FDA UDI
    Tyber Medical, LLC·M69520502P241088S0·PLIF TiPEEK 24mm x 8mm x 10mm x 8 deg

    Grosz Play Feel

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

    TRIFUSION, MODEL 0609190/0659350

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 7, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·November 21, 2008

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·August 17, 2011

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code NIQ·September 1, 2006

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 11, 2013

    PINNACLE MTL INS NEUT36IDX62OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 11, 2013

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 11, 2013

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 11, 2013

    PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 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