BEUDAMED
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    Hepatitis A Test (Antibody And Igm Antibody)

    FDA Pre-Market Approval
    FDA Class 2 ·HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM

    Hepatitis A Test (Antibody And Igm Antibody)

    FDA Pre-Market Approval
    FDA Class 2 ·HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM

    Integra® Total Foot System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780118428·The locking rearfoot screw is used in the Integ...

    Total Foot System 2

    FDA UDI
    Smith & Nephew, Inc.·00885556838822·3.5mm plate locking screw 18mm

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707034603·.018 Lower Value Brand Of Niti Natural Form Arc...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707028314·WEB 1ST MOLAR BANDS n.UL 18

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    Immunohistochemistry Assay, Antibody, Claudin 18

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024551268·

    SAFE-T ARM BOARD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·ProACT Adjustable Continence Therapy for Men

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·ProACT Adjustable Continence Therapy for Men

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    Immunohistochemistry Assay, Antibody, Claudin 18

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·ProACT™ Adjustable Continence Therapy for Men

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·ProACT™ Adjustable Continence Therapy for Men

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·ProACT Adjustable Continence Therapy for Men

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 23, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 13, 2012

    CAPSURE SP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 10, 2010