7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VAGATEX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ANALYZER, SELECTIVE, ELECTRONIC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Catalys Precision Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 30, 2014
LCS COMPLETE FEM CEM L LG
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code NJL·October 11, 2012
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·May 14, 2015
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025