8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
FDA 510(k)
FDA Class 2
·Anesthesiology
ULTRAZYME PLUS & SYSTEMATE LDH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POST MYDRIATIC SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 11, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 10, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC·Product code LZG·July 18, 2014
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017