BEUDAMED
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    CARPAL TUNNEL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VARIAX

    FDA UDI
    Stryker GmbH·07613327125597·Screw Rack, T8

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9402340·

    ASPIRON ACP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MOTOR EM210 LEGEND STYLUS TOUCH

    FDA Adverse Event
    Malfunction ·XOMED MFG JACKSONVILLE·Product code ERL·February 2, 2013

    UNKNOWN DEPUY ASR IMPLANTS

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

    SOLIS CERVICAL CAGE SIZE H 5 MM L 12 MM

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

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    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

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    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