BEUDAMED
    27 results · 21ms · Sources: EU EUDAMED, US FDA

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    WBR, MODEL HR

    FDA 510(k)
    FDA Class 2 ·Radiology

    WarmTouch

    FDA UDI
    Covidien LP·20884521063195·Upper Body Blanket

    Pratt ExLarge 9pc Dilator Set

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030870·Pratt ExLarge 9pc Dilator Set 45-47 Fr (15-15.6...

    DENTATUS AB

    FDA registration
    DENTATUS AB·16 products·🇸🇪 Sweden

    THROMBOREL S

    FDA 510(k)
    FDA Class 2 ·Hematology

    KM-10 TENS ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017

    WARM TOUCH

    FDA Adverse Event
    Injury ·PLEXUS MANUFACTURING SDN. BHD·Product code DWJ·January 5, 2018

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017

    WARMTOUCH

    FDA Adverse Event
    Injury ·MMJ SA DE CV (USD)·Product code DWJ·January 16, 2025

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·March 28, 2013

    DEEP BRAIN STIMULATION LEAD

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

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2020

    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