BEUDAMED
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    DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450146309·

    UNK

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014

    LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NONE - SEE PHYSICIAN COMMENTS IN H10.

    FDA Adverse Event
    Injury ·Product code JWH·October 16, 2013

    HEARTSTART XL

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 4, 2013

    GLOBAL ADVANTAGE ECC HD 44X21

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWS·April 11, 2011

    120V AUTOCAT IAB PUMP

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·May 22, 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