9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TuxDeluxe (Size 1 6100B, Size 2 6101B)
FDA 510(k)
FDA Class 2
·Dental
Sklar®
FDA UDI
SKLAR CORPORATION·10649111357916·SKLARLITEXD ROCH-PEAN STR 6.25
ACCU-CHEK ADVANTAGE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
U&U STERILE HYPODERMIC NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
COBAS 6000 C501MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·November 13, 2008
CONVECTIVE PATIENT WARMER
FDA Adverse Event
Malfunction
·STRYKER CORP DBA GAYMAR·Product code DWJ·July 19, 2011
RESTORE ULTRA
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code LGW·July 18, 2013