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

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    Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

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

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10

    Caremed Reusable & Disposable SPO2 Sensors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYDRASHIFT 2/4 isatuximab

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCU-CHEK SENSOR COMFORT

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code NBW·December 5, 2008

    CLINITEK STATUS+ ANALYZER

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.·Product code LCX·September 1, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 29, 2013

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 25, 2022

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 25, 2022

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 25, 2022

    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 7, 2018

    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 7, 2018

    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