BEUDAMED
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    NEOSCREEN ELISA HYDROXYPROGESTERONE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VARIAX

    FDA UDI
    Stryker GmbH·07613327125658·Screw Rack Non-Locking Screws, T10

    Trinias

    FDA UDI
    SHIMADZU CORPORATION·04540217049080·

    Pitkar Spinal Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRASONIC SCALER

    FDA 510(k)
    FDA Class 2 ·Dental

    ASR ACETABULAR IMPLANT 50

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 23, 2010

    MOTOR EM210 LEGEND STYLUS TOUCH

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code ERL·February 2, 2013

    AVS UNILIF SPACER 9 X 30 X 0DEG - 11MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code MAX·July 17, 2014

    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

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017