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    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sharper Image

    FDA UDI
    Merchsource, LLC·00843479198263·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040076002·Carbide Bur FG Clinic 331

    OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE

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

    TRI-FIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENCODE

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code NHA·March 13, 2013

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 2, 2011

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·May 1, 2014

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·April 28, 2014

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·March 27, 2014

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    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