8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEUROFAX, MODEL EEG-1100A
FDA 510(k)
FDA Class 2
·Neurology
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Straumann Variobase C
FDA 510(k)
FDA Class 2
·Dental
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·March 7, 2013
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 16, 2011
TRANSVENE RV
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·August 8, 2014
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020