95 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHASE BLOOD VESSEL SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
SUNIRAY 5.2
FDA 510(k)
FDA Class 2
·Radiology
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
TOTAL ASR ACET IMP SIZE 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·February 21, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·January 20, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 1, 2014
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