ClearanceBrief
Company ยท DK

Medtronic Functional Diagnostics A/S

FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2002. Name variants (Inc, Corp, punctuation) are merged.

11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FFXSystem, Gastrointestinal Motility (Electrical)7
IKTElectrode, Needle, Diagnostic Electromyograph2
FENDevice, Cystometric, Hydraulic1
MYESystem, Electrogastrography (Egg)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 21, 2002K014269POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
Medtronic Functional Diagnostics A/S, DK
MYE
Nov 8, 2002K011471BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
Medtronic Functional Diagnostics A/S, DK
FFX
Aug 15, 2001K002992DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
Medtronic Functional Diagnostics A/S, DK
IKT
Aug 10, 2001K011472POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
Medtronic Functional Diagnostics A/S, DK
FFX
Feb 7, 2001K010130POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
Medtronic Functional Diagnostics A/S, DK
FFX
May 5, 2000K000386POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
Medtronic Functional Diagnostics A/S, DK
FFX
Feb 28, 2000K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101
Medtronic Functional Diagnostics A/S, DK
FEN
Nov 10, 1999K992713POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
Medtronic Functional Diagnostics A/S, DK
FFX
Jul 15, 1999K991389ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
Medtronic Functional Diagnostics A/S, DK
FFX
Mar 9, 1999K990375DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
Medtronic Functional Diagnostics A/S, DK
IKT
Feb 4, 1999K981733DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
Medtronic Functional Diagnostics A/S, DK
FFX

Latest recalls

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