8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endoscopic Video Image Processor (RP-IPD-V1000F)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002428·External 3.5mm Direct Pick-up Coping, Non-hexed
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ITST Intertrochanteric/Subtrochanteric Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code FRC·November 11, 2014
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 12, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 5, 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