8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EZ-IO Intraosseous Vascular Access System
FDA 510(k)
FDA Class 2
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022316·FPS 1.6mm Pilot for 2.7 Screw Drill Guide Compr...
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Single-Use Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 11, 2024
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC·Product code MIH·November 13, 2008
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·September 1, 2011
LIMELIGHT
FDA Adverse Event
Injury
·CUTERA, INC.·Product code GEX·November 21, 2012