10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO INTRASTENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
ARGEDENT 38
FDA 510(k)
FDA Class 2
·Dental
BIOPSYS DRIVERS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KNW·June 8, 2006
BIOPSYS DRIVERS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATIA)·Product code KNW·June 8, 2006
BIOPSYS DRIVERS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code KNW·June 7, 2006
DRAGER EVITA INFINITY V500
FDA Adverse Event
Malfunction
·DRAGER MEDICAL INC·Product code CBK·February 10, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 4, 2011
CAPSURE VDD 2
FDA Adverse Event
Injury
·MPRI·Product code DXY·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