96 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·July 19, 2021
UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·April 29, 2021
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 12, 2022
UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·November 23, 2020
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·December 31, 2020
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·August 27, 2020
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 20, 2024
TRI-TOME PC PROTECTOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 12, 2022
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·November 18, 2021
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 21, 2024
COTTON CANNULATOME
FDA Adverse Event
Death
·COOK ENDOSCOPY·Product code KNS·October 14, 2021
D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·November 17, 2021
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·December 9, 2021
TRI-TOME PC PROTECTOR
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·July 12, 2021
TRI-TOME PC PROTECTOR
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·July 12, 2021
TRI-TOME PC PROTECTOR
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·July 14, 2021
DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·July 19, 2021
TRI-TOME PC PROTECTOR
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·August 13, 2021
COTTON CANNULATOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·December 16, 2024