BEUDAMED
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    EXCELLA-M SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STb Copper Ni-Ti

    FDA UDI
    ORMCO CORPORATION·00889989025033·STb STRAIGHTWIRE CUNITI 18 x 18 LG PK10

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20421431·Arch wires Titanol Superelastic Straight-Arch-F...

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Injury ·BD·Product code FMI·February 2, 2015

    24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM

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

    *

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED·Product code GFA·March 28, 2013

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 6, 2011

    VITALITY DS

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013