7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NXSTAGE SYSTEM ONE WITH NXVIEW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
VNUS VESSEL AND TISSUE COAGULATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013
ENTERRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·June 15, 2011
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICRO TYPING SYSTEMS, INC.·Product code KSZ·August 21, 2008
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023