BEUDAMED
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    DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517962492·Brigade Lateral Trial, 7x34x32mm 10°

    Sapphire 3

    Device
    EU MDD · Eu Md Class 3 ·OrbusNeich Medical, B.V.·On the market·8 countries

    US ENDOSCOPY CYTOLOGY BRUSH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ODYSSEY LX, MODEL 211320

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 30, 2014

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEA, AVENIDA HENEQUEN·Product code BTR·January 2, 2013

    ENDOPOUCH RETRIEVER SPEC BAG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·November 19, 2010

    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