9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROFILE MULTI-PLATFORM SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONDREX P.A.L. SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 12, 2017
ANIT-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 12, 2013
RSVR MMT-103A 10PK 3CC 13L STRL
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·June 30, 2008
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 19, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012