7 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FlareHawk Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
FILTEK BULK FILL FLOWABLE RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·November 4, 2008
HERNIA REPAIR MESH
FDA Adverse Event
Injury
·GORE·Product code FTL·August 17, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
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