7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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F&P Optiflow+ Duet Nasal Cannula
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO HERMES O.R. CONTROL CENTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUICK RELAX PRO
FDA 510(k)
FDA Class 2
·Neurology
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·September 1, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES,INC·Product code MIH·July 3, 2013
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
FDA Enforcement
Class II
·Ongoing·Apellis Pharmaceuticals, Inc.·October 11, 2023