BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    MODELS EMS 5.0, EMS 5.1

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code JDS·February 13, 2017

    MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code FMI·February 13, 2019

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 23, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 31, 2011

    TRANSVENE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·July 10, 2008

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 5, 2016

    7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the open design of the system, the Signa 0.7T Signa OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles. . .

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

    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