Data / Medical devices / System, Hemodialysis, Remote Accessories
System, Hemodialysis, Remote Accessories (MON): 13 FDA-registered makers in 7 countries
13 establishments in 7 countries are registered with the FDA to make System, Hemodialysis, Remote Accessories (product code MON, Class 1, 21 CFR 876.5820). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MON
- Device class
- 1
- Regulation
- 876.5820
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Dominican Republic | 2 |
| India | 2 |
| Malta | 1 |
| Italy | 1 |
| United Kingdom | 1 |
| Switzerland | 1 |
Makers of System, Hemodialysis, Remote Accessories
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare, S.A. | Haina San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Innovations & Business Solutions Pvt. Ltd. | Bangalore Karnataka, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Limited | Marsa, Malta | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gambro Dasco S.P.A., Blood Line Division | MEDOLLA Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metrix Dominicana S.R.L. | HAINA San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Molded Products Inc. | Harlan, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quanta Dialysis Technologies Ltd | Warwick Warwickshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reprocessing Products Corporation (RPC) | Tucson, AZ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimark El Paso | El Paso, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vantive Healthcare Technologies Private Limited | Bangalore Karnataka, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vasc-Alert, LLC | West Lafayette, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.