11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 14, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 13, 2011
ATRIUM ICAST COVERED STENTS
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code JCT·July 17, 2014
IMPELLA CP
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·November 3, 2025