BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    NON-EUGENOL TEMPORARY CEMENT

    FDA 510(k)
    FDA Class 1 ·Dental

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101212·Burs FGSL 1557, Pkg/5

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450311431·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450196748·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540756220·MULTI-PURPOSE IMPACTOR

    ROSA®

    FDA UDI
    Orthosoft Inc·00887868552120·

    VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9

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

    S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 25, 2013

    GORE DRYSEAL SHEATH

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC.·Product code DYB·March 7, 2011

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016