8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
COULTER URIC ACID REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756739412·CV B W AUX PACK
THOMPSON TYPE RASP W/TOMMY BAR
FDA 510(k)
FDA Class 1
·Orthopedic
VITRECTOMY PACK #J120
FDA 510(k)
FDA Class 2
·Ophthalmic
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·November 12, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 4, 2013
REALSEAL SE
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·June 26, 2014
Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017