7 results
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18ms
·
Sources: EU EUDAMED, US FDA
DELFIA (TM) HFSH KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NobelProcera HT ML FCZ Bridge
FDA 510(k)
FDA Class 2
·Dental
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
FDA 510(k)
FDA Class 2
·Cardiovascular
INSYNC MAXIMO
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
ENDOSTAT ELECTROSURGICAL UNIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·October 8, 2010
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012