BEUDAMED
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    IMAX 9.5 STERILIZERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776161835·Weitlaner Retractor

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776293550·Weitlaner Retractor sharp, with hinged arms

    TISSUELINK BIPOLAR FLOATING BALL DEVICE

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

    SEPRAGEL SINUS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LIFESTENT VALEO BILIARY STENT

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009

    LIFESTENT VALEO BILIARY STENT

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009

    LIFESTENT VALEO VASCULAR STENT

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·August 9, 2010

    VALEO VASCULAR STENT

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·September 3, 2010

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    SYNERGY EZ PATIENT PROGRAMMER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·May 22, 2008

    ACTIVA RC

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·April 11, 2011

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014