9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASAHI SASUKE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
ALL-BOUND 3
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 11, 2013
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 28, 2011
ULTRASITE OUTLOOK (SAFETY INFUSION SYSTEM IV SET)
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC.·Product code FPA·September 24, 2008
INSPIRE HVR DUAL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTN·November 12, 2024
INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·November 18, 2022