9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elecsys FT4 IV
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
DEPUY MITEK, LLC·10886705007332·Cortical Screw 4.5mm x 56mm
Becker External Drainage and Monitoring System
FDA 510(k)
FDA Class 2
·Neurology
EASI 12 LEAD ALGORITHM
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 12, 2019
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·November 4, 2008
COBAS INTEGRA 400
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 23, 2011
OT PING 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