BEUDAMED
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    FREEDOM CONSTRAINED LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOAR Retractor System

    FDA UDI
    SPINEOLOGY INC.·M7403030047·14mm Dilator

    SYNOVO HIP COMPONENTS

    FDA UDI
    Synovo Production·00814193025685·HIP FEMORAL RESURFACING CUP - 47 MM

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023070·B-P HIP FEMORAL RESURFACING CUP W/BIOCOAT & W/U...

    Biocore9 Femoral Resurfacing Component

    FDA UDI
    Biocore9, LLC·00810068850437·Biocore9 Femoral Resurfacing Head Component 47 mm

    INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST

    FDA 510(k)
    FDA Unclassified ·Unknown

    AMBULATORY ENTERAL NUTRITION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MARY HITCHCOCK HANOVER NH 1

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·November 7, 2012

    PATIENT DATA MODULE

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·April 21, 2015

    Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052

    FDA Enforcement
    Class II ·Ongoing·Synovo Production·April 17, 2024

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·CORDIS PRECISE NITINOL STENT SYSTEM

    SMALL PERIPHERAL CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·April 2, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 30, 2014

    POWERED MULTIFIRE ENDO GIA 60-2.5 DLU

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GCJ·April 15, 2008

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENTS SYSTEMS

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISE Pro Rx Nitinol Stent System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Cordis PRECISE Nitinol Stent System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISE AND PRECISE RX NITINOL STENT SYSTEMS