Medtronic Functional Diagnostics A/S
DenmarkFDA applicant, unverified
- Devices
- 11
What Medtronic Functional Diagnostics A/S makes
The company manufactures diagnostic systems for gastrointestinal and urological function testing, including neuro-urodynamic suites, anorectal manometry systems, esophageal manometry devices, and pH monitoring applications. It also produces disposable needle electrodes for electrophysiological measurements, as well as electrogastrography software for assessing gastric motility. These tools are designed for clinical use in assessing digestive and lower urinary tract function.
The portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance pathway. Products are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. regulatory requirements. The company is based in the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Medtronic Functional Diagnostics A/S have in the registry?
The registry currently lists 11 devices for Medtronic Functional Diagnostics A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Functional Diagnostics A/S's devices?
Among its 11 most recently registered devices, Medtronic Functional Diagnostics A/S has devices listed in FDA 510(k) (11 devices).
What risk classes do Medtronic Functional Diagnostics A/S's devices fall under?
Among its 11 most recently registered devices, the classes recorded for Medtronic Functional Diagnostics A/S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Functional Diagnostics A/S in the registry?
The most recently registered devices listed for Medtronic Functional Diagnostics A/S include NEURO URODYNAMIC SUITE, MODEL 9032E0101, BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER, POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID and ANORECTAL MANOMETRY SUITE, MODEL 9032S0201.