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

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    BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    CAPSTONE PTC™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169187207·SPACER 3993612 36MM X 12MM

    artegral life

    FDA UDI
    Merz Dental GmbH·D7091993612·anteriors; shade BL3; mould ITS

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198383·AK3 PS Insert Trial Size 6, 12mm

    AMT Suture Delivery System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SYNGO.PLAZA

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 7, 2013

    SELECTSECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·August 8, 2014

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·January 6, 2011

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 2015