8 results
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17ms
·
Sources: EU EUDAMED, US FDA
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
FDA 510(k)
FDA Class 2
·Immunology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515242173·McKenty Sphenoid Punch, rev, 7"
SUTURE KITS STERILIZED W/GAMA RADIATION
FDA 510(k)
FDA Unclassified
·Unknown
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
FDA 510(k)
FDA Class 2
·Microbiology
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·June 24, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W.L. GORE & ASSOCIATES, INC.·Product code MIH·December 9, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·January 28, 2013
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015