69 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL
FDA 510(k)
FDA Class 2
·Dental
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741314300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674131430060·
NC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600303244·
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131431·TiBase NC RP 1.2G NE
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131430·TiBase NC NP 1.2G NE
MLS-AC DERMA SCANNER
FDA 510(k)
FDA Class 2
·Physical Medicine
CEMEX SYSTEM FAST
FDA 510(k)
FDA Class 2
·Orthopedic
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 3, 2017
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·February 2, 2016
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 27, 2016
FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 29, 2020
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·October 1, 2014
PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP
FDA Adverse Event
Injury
·COVIDIEN MEDICAL PRODUCTS·Product code GDW·May 9, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011
EVOLUTION BILIARY CONTROLLED-RELEASE STENT-FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·March 25, 2015
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·April 24, 2015
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·March 12, 2015
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·May 4, 2017
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025