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Data / Medical devices / Table, Cystometric, Electric

Table, Cystometric, Electric (MMZ): 9 FDA-registered makers in 5 countries

9 establishments in 5 countries are registered with the FDA to make Table, Cystometric, Electric (product code MMZ, Class 2, 21 CFR 876.4890). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on November 25, 2003, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MMZ
Device class
2
Regulation
876.4890
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States4
Sweden2
Dominican Republic1
France1
Mexico1

Makers of Table, Cystometric, Electric

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Accogent PauschEatontown, NJ, United StatesManufacturer0000api.fda.gov
Das Medical International, SRLLa Romana, Dominican RepublicManufacturer0000api.fda.gov
EDAP TMS France SAVaulx en Velin Rhone, FranceManufacturer0000api.fda.gov
Image Diagnostics, Inc.Fitchburg, MA, United StatesManufacturer0000api.fda.gov
Oakworks, Inc.New Freedom, PA, United StatesManufacturer0000api.fda.gov
Posey S. de R.L. de C.V.Tijuana, Baja California Mexico, MexicoManufacturer0000api.fda.gov
Samhall ABSvenstavik Jamtland, SwedenContract manufacturer0000api.fda.gov
Sonesta Medical ABStockholm, SwedenExporter to the US, Manufacturer, Specification developer0010api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesSpecification developer0000api.fda.gov

Updated November 25, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.