BEUDAMED
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    BOUFFANT CAP

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

    Everest & Jennings

    FDA UDI
    GF HEALTH PRODUCTS, INC.·M36889402281·DURA-GEL SPP-AT

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9402280·

    MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISPOSABLE TRACHEAL TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·June 20, 2014

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 2, 2013

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·December 23, 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

    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