7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SubtleREFORMAT (1.x)
FDA 510(k)
FDA Class 2
·Radiology
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 2, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
BIO-COMPOSITE TRANSFIX 5 X 50MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025