BEUDAMED
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    POLYAXIAL HEMISPHERICAL SPINAL SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·March 14, 2016

    GREAT TOE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code MNL·March 14, 2016

    SPINEMED TABLE - FDA 510(K) K051013

    FDA Adverse Event
    Other ·CERT HEALTH SCIENCES, LLC·Product code ITH·July 16, 2007

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 10, 2013

    CD HORIZON AGILE SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code NQP·May 22, 2008

    LAMITRODE 88 LEAD, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·April 5, 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