# Medtronic Functional Diagnostics A/S

- Location (FDA's records): Skovlunde, DK
- FDA decisions: 11 (1999–2002): 11 510(k) clearances
- Product codes: FFX (7), IKT (2), MYE (1), FEN (1)
- Predicates its devices cite: 11 (1 its own); citations of its devices by later devices: 9 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synectics-Dantec: 3 (https://510kreport.com/company/synectics-dantec)
- Synectics Medical, Inc.: 3 (https://510kreport.com/company/synectics-medical)
- 3pm Co., Inc.: 1 (https://510kreport.com/company/3pm)
- Dantec Medical, Inc.: 1 (https://510kreport.com/company/dantec-medical)
- Mckenna & Cuneo: 1 (https://510kreport.com/company/mckenna-cuneo)
- Medtronic-Synectics: 1 (https://510kreport.com/company/medtronic-synectics)

## Firms that cite its devices most
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Given Imaging, Ltd.: 1 (https://510kreport.com/company/given-imaging)
- Sierra Scientific Instruments, Inc.: 1 (https://510kreport.com/company/sierra-scientific-instruments)
- Xian Friendship Electronics Co., Ltd.: 1 (https://510kreport.com/company/xian-friendship-electronics)
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)
- G-Tech Medical: 1 (https://510kreport.com/company/g-tech-medical)
- Alimetry, Ltd.: 1 (https://510kreport.com/company/alimetry)
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)

## Its most-cited devices
- K014269: Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102 (2002), cited by 2
- K002992: Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 (2001), cited by 2
- K011472: Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID (2001), cited by 2
- K990375: Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 (1999), cited by 1
- K000386: Polygram 98 Anorectal Function Testing Application, Model 9043S0111 (2000), cited by 1
- K981733: Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 (1999), cited by 1

## Recent decisions
- K014269: Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102 (Nov 21, 2002)
- K011471: Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober (Nov 8, 2002)
- K002992: Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 (Aug 15, 2001)
- K011472: Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID (Aug 10, 2001)
- K010130: Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103 (Feb 7, 2001)
- K000386: Polygram 98 Anorectal Function Testing Application, Model 9043S0111 (May 5, 2000)
- K992715: Neuro Urodynamic Suite, Model 9032E0101 (Feb 28, 2000)
- K992713: Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101 (Nov 10, 1999)

Source page: https://510kreport.com/company/medtronic-functional-diagnostics-a-s