102 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LiverMultiScan
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111355370·ROCH-OCHSNER FCP CVD 1X2, 9"
NGARDE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ANGIOSCULPT PTA SCORING BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
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
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2013
ENDEAVOR RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 20, 2011
PUMP MMT-722RNAB PRDGM INS BL EN RC
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·September 19, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Injury
·ANGIOSCORE, INC·Product code LIT·March 29, 2016
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