BEUDAMED
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    MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM

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

    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

    ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHROMAGEN V3.0 READING AID SOFT CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 11, 2013

    HUDSON SINGLE-HEATED LIMB CIRCUIT ACCESSORY

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·March 1, 2011

    BIOMET 71MM TIBIAL PLATE

    FDA Adverse Event
    Injury ·BIOMET·Product code HSH·May 22, 2008

    TI PANGEA LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code NKB·June 5, 2012

    TI PANGEA LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code NKB·June 5, 2012

    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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016