9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
AGGLUTINOTEST-RHEUMATOID ARTHRITIS
FDA 510(k)
FDA Class 2
·Immunology
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
FDA 510(k)
FDA Class 1
·Ophthalmic
Intellijoint® Navigation System
FDA 510(k)
FDA Class 2
·Neurology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS, HEARTSTREAM·Product code MKJ·August 6, 2010
PALL ULTIPOR 25 BREATHING SYSTEM FILTER
FDA Adverse Event
Injury
·PALL NEWQUAY·Product code CAH·July 13, 2018
PALL ULTIPOR 100 BREATHING SYSTEM FILTER
FDA Adverse Event
Injury
·PALL NEWQUAY·Product code CAH·April 18, 2017
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018