9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNCHRON CREATINE KINASE REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code CGS·June 17, 2011
UniPulse
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
FDA 510(k)
FDA Class 2
·Cardiovascular
OPTIFLUX 180NRE DIALYZER FINISHED ASSY
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 25, 2014
VASOVIEW 7 XB
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·February 22, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 9, 2011
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012