9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AXIOM HYDROMER WOUND DRAINS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
REHASTIM 2, ERIGOPRO (FES)
FDA 510(k)
FDA Class 2
·Neurology
VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
FDA 510(k)
FDA Class 2
·Dental
EASYPUMP
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·October 7, 2008
2008K HEMODIALYSIS SYS OLC/DIASAFE PLUS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 27, 2014
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code JDI·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 13, 2010
Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 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