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    GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496030874·STRONG, SIZE S, NOISETTE, MICRO-MASSAGING BERMU...

    COR-KNOT® QUICK LOAD®

    FDA UDI
    LSI Solutions, Inc.·00850200006056·COR-KNOT® QUICK LOAD® 6-POUCH

    Pratt Dilator Extra Large

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030874·Pratt Dilator Extra Large 57-59 Fr (19-19.6 mm)

    CBC-4K HEMATOLOGY CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ATS 3000 TOURNIQUET

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code KCY·March 28, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·March 4, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 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