8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wrist Blood Pressure Monitor Model BP6100
FDA 510(k)
FDA Class 2
·Cardiovascular
STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635
FDA 510(k)
FDA Class 2
·Neurology
ENDOTRACHEAL TUBE CHANGERS
FDA 510(k)
FDA Class 2
·Anesthesiology
GORE DUALMESH PLUS BIOMATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTL·November 13, 2018
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·June 14, 2013
D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·July 15, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 23, 2011
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014