12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GSI VIEWER WITH VUE OPTION
FDA 510(k)
FDA Class 2
·Radiology
Z Liquid HT D4-C 100ml
FDA UDI
ARGEN CORPORATION, THE·D818121827·Dental porcelain/ceramic restoration kit
HemoCue® Hb301 Analyzer
FDA UDI
Hemocue AB·07311091218278·HemoCue Hb301 Analyzer g/dL
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OSTEOSCAF
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
V-CARE INFANT RESUCITATOR
FDA Adverse Event
Malfunction
·VENTLAB·Product code BTM·May 14, 2013
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 28, 2014
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CGN·May 20, 2011
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·September 3, 2015
VALVE HANCOCK II
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·September 3, 2015
PLATE ADAPTER DIST. LAT. FEMUR RIGHT
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·May 11, 2017