BEUDAMED
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    NEW GEAR RELEASABLE HEADGEAR

    FDA 510(k)
    FDA Class 2 ·Dental

    SpiritMB

    FDA UDI
    ORMCO CORPORATION·00889989007077·ID U - Twin - Lower-Right Cuspid - Purple

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690102007·All Poly 3 Peg Patella 41 mm x 10 mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127741·Patella Trial 41mm x 10mm

    GREENLIGHT 300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVOLVE Nitric Oxide Delivery System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·February 3, 2013

    35 CM BIPOLAR LEAD

    FDA Adverse Event
    Injury ·GREATBATCH MEDICAL·Product code DTB·December 20, 2010

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020