9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Healgen Rapid COVID-19 Antigen Test
FDA 510(k)
FDA Class 2
·Microbiology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102725·CHANG MICROFINGER LEFT
OSTEOSPAN MORPHEUS
FDA 510(k)
FDA Class 2
·Orthopedic
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·November 6, 2014
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 18, 2011
POLAR CARE KODIAK
FDA Adverse Event
Malfunction
·BREG·Product code ILO·July 2, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025