7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO
FDA 510(k)
FDA Class 2
·Microbiology
E.G. SCAN II ESPHAGOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
O'REGAN DISPOSABLE ANOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·January 17, 2013
ENDURITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023