Data / Medical devices / Protector, Transducer, Dialysis
Protector, Transducer, Dialysis (FIB): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Protector, Transducer, Dialysis (product code FIB, Class 2, 21 CFR 876.5820). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on June 28, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FIB
- Device class
- 2
- Regulation
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| Mexico | 3 |
| United States | 3 |
| China | 1 |
| Ireland | 1 |
| Thailand | 1 |
Makers of Protector, Transducer, Dialysis
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 |
|---|---|---|---|---|---|---|---|---|
| Bain Medical Equipment(guangzhou) Co., Ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 1 | June 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 1 | December 1, 2000 | 0 | 0 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 1 | December 1, 2000 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Medical Care Renal Therapies Group, LLC | Waltham, MA, United States | Complaint file establishment, Specification developer | 1 | December 1, 2000 | 0 | 0 | 0 | api.fda.gov |
| Molded Products Inc. | Harlan, IA, United States | Manufacturer | 1 | January 14, 1994 | 0 | 0 | 0 | api.fda.gov |
| Merck Millipore Ltd. | COUNTY CORK Munster, Ireland | Manufacturer | 1 | April 21, 1994 | 0 | 0 | 0 | api.fda.gov |
| Nxstage Medical, Inc. | Lawrence, MA, United States | Complaint file establishment, Specification developer | 1 | November 25, 1998 | 0 | 0 | 0 | api.fda.gov |
| Nipro (Thailand) Corporation Limited | SENA Phra Nakhon Si Ayutthaya, Thailand | Manufacturer | 1 | February 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Medimexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 28, 2024. 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.