13 results
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20ms
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Sources: EU EUDAMED, US FDA
CORNINGS MAGIC FERRITIN RADIOIMMUNO-
FDA 510(k)
FDA Class 2
·Immunology
FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
FDA 510(k)
FDA Class 2
·Cardiovascular
MACH LED 2SC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UniTip Catheter
FDA UDI
Unisensor AG·07640172973769·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971758·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971765·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971772·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971789·
MENTOR MEMORYGEL XTRA BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·September 5, 2023
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 30, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 20, 2012
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 21, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018