10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DEN TEMP
FDA 510(k)
FDA Class 1
·Dental
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268215811·CUSTOM SURGICAL KIT VEIN PACK
HEMOSORB
FDA 510(k)
FDA Unclassified
·Unknown
BOX PEEK VBR SYSTEM,
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 16, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MGB·November 6, 2012
PUMP MMT-512LNAL PRDGM INS CL EN US LN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·August 26, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 24, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 27, 2020
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