7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IRIS-XP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
VISIOFOCUS
FDA 510(k)
FDA Class 2
·General Hospital
AU5800(R) CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GOODBABY·Product code ITJ·October 30, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023