8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)
FDA 510(k)
FDA Class 2
·General Hospital
Auto Segmentation
FDA 510(k)
FDA Class 2
·Radiology
Swedge Pedicle Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM CLARITY SOFTWARE
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·December 15, 2022
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 7, 2024
COBAS 6000 E601 MODULES
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·November 4, 2008
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 29, 2011
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·July 16, 2013