BEUDAMED
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    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company

    FDA Recall
    Terminated ·Spinal Concepts, Inc·Product code KWQ·March 1, 2004

    One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company

    FDA Recall
    Terminated ·Spinal Concepts, Inc·Product code KWQ·March 1, 2004

    Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

    FDA Recall
    Terminated ·Laerdal Medical Corporation·Product code BTM·December 23, 2003

    GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·November 18, 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