10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707065661·INTRAORAL ELASTICS 2,5 oz 5/16" blue
CBC-SF
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO T-REX BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Cardiovascular
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·April 23, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
MAX PRI TIB BRNG 12X79/83
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 2, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 16, 2011
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code OOI·July 11, 2012