BEUDAMED
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    SHILEY SPECIALIZED TRACHEOSTOMY TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517962478·Brigade Lateral Trial, 14x34x32mm 8°

    Gravity Compensating Accessory

    FDA UDI
    INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780033523·The Gravity Compensating Accessory (GCA) is des...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515229396·Perforating Needle, str, 6 3/8"

    Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACSYS SHEARER ACETABULAR CUP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GRAVITY COMPENSATING ACCESSORY,MEDIUM

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code JXG·January 10, 2017

    SPACELABS TELEMETRY RECEIVER MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE INC.·Product code DSI·April 30, 2015

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 30, 2014

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·November 19, 2010

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·January 9, 2013

    SPACELABS DIGITAL TELEMETRY TRANSMITTER

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE INC.·Product code MHX·April 21, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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