8 results
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17ms
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Sources: EU EUDAMED, US FDA
CTA MEDIUM TUBE
FDA 510(k)
FDA Class 1
·Microbiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471172425·RECIP. BLADE - DE SOUTTER MICRO 8.7 x 25.5 x 0....
MDT CHEMITEST SEE-THRU BAG
FDA 510(k)
FDA Class 2
·General Hospital
TOILET SEAT RAISED
FDA 510(k)
FDA Class 1
·Physical Medicine
UNKNOWN M2A HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 28, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 15, 2012
ALLEGRETTO WAVE
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·September 10, 2010
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·February 26, 2014