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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Devices

BrandModelCompanyProduct codesPrimary DI
Disposable MRI Kit with Check ValveSQK 65VABAYER MEDICAL CARE INC.LNH00616258005478
Female – Female AdapterFFA 50Bayer Medical Care Inc.LNH00616258024998
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258007298
Female - Female Adapter FFA 50 BAYER MEDICAL CARE INC.LNH00616258021669
Disposable MRI Kit A Disposable Kit for use with the 65/65 MR Injector from BayeSQK 65SBAYER MEDICAL CARE INC.LNH00616258005515
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258005522
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258021126
Disposable MRI Kit with Check ValveSQK 65VABAYER MEDICAL CARE INC.LNH00616258010038
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258007816
MRI Integral “T” with Check Valve for MEDRAD® Spectris MR InjectorSIT 96VBayer Medical Care Inc.LNH00616258024486
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258007380
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258010007
Disposable MRI Kit with Check ValveSQK 65VSBAYER MEDICAL CARE INC.LNH00616258007342
Disposable MRI Kit with Check ValveSQK 65VSBAYER MEDICAL CARE INC.LNH00616258021584
Female - Female AdapterFFA 50BAYER MEDICAL CARE INC.LNH00616258007274
Disposable MRI Kit with Check ValveSQK 65VABAYER MEDICAL CARE INC.LNH00616258021560
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258021133
Disposable MRI Kit with Check ValveSQK 65VSBAYER MEDICAL CARE INC.LNH00616258005447
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258021102
Female - Female Adapter FFA 50 BAYER MEDICAL CARE INC.LNH00616258010113
Disposable MRI Kit with Check ValveSQK 65VSBAYER MEDICAL CARE INC.LNH00616258007779
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258021836
Disposable MRI Kit with Check ValveSQK 65VSBayer Medical Care Inc.LNH00616258024301
"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"SIT 96VBAYER MEDICAL CARE INC.LNH00616258021119
Female - Female AdapterFFA 50BAYER MEDICAL CARE INC.LNH00616258005676