8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TECHNA-CUT ASPIRATION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
VersaViewer
FDA 510(k)
FDA Class 2
·Radiology
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2014
SROM*STM ST,30+4L NK,18X13X160
FDA Adverse Event
Injury
·DEPUY IRELAND ? REG. # 9616671·Product code JDI·February 5, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·December 21, 2010
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NPT·November 10, 2025
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026