23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 19, 2022
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 15, 2023
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·June 28, 2023
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·March 5, 2021
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036784·Trial Rasp, Assembly, Lordotic, 10mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036777·Trial Rasp, Assembly, Lordotic, 9mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036753·Trial Rasp, Assembly, Lordotic, 7mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036760·Trial Rasp, Assembly, Lordotic, 8mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036739·Trial Rasp, Assembly, Lordotic, 5mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036746·Trial Rasp, Assembly, Lordotic, 6mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036791·Trial Rasp, Assembly, Lordotic, 11mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036807·Trial Rasp, Assembly, Lordotic, 12mm
ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
FDA 510(k)
FDA Class 2
·Dental
ELECSYS DIGOXIN CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·October 10, 2014
HUMAPEN ERGO, TEAL/CLEAR CH
FDA Adverse Event
Malfunction
·ELI LILLY AND COMPANY·Product code FMF·September 17, 2008
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 12, 2017