8 results
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17ms
·
Sources: EU EUDAMED, US FDA
NYLON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KNEEALIGN SYSTEM WITH REFERENCE SENSOR
FDA 510(k)
FDA Class 2
·Neurology
PAM PLUS
FDA 510(k)
FDA Class 1
·Physical Medicine
GUIDANT INSIGNIA
FDA Adverse Event
BOSTON SCIENTIFIC·Product code LWP·March 4, 2013
HUDSON PEDIATRIC BREATHING CIRCUIT, 30"
FDA Adverse Event
Malfunction
·TELEFLEX·Product code OFP·July 24, 2014
SOFTCLIX® PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·February 16, 2011
CLOSUREFAST CATHETER
FDA Adverse Event
Injury
·COVIDIEN·Product code GEI·December 15, 2022
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·April 3, 2013