Data / Medical devices / System, Evacuator, Fluid
System, Evacuator, Fluid (FHF): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make System, Evacuator, Fluid (product code FHF, Class 2, 21 CFR 876.4370). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on May 19, 2010, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FHF
- Device class
- 2
- Regulation
- 876.4370
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 2 |
| Hong Kong | 1 |
| Monaco | 1 |
Makers of System, Evacuator, Fluid
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 |
|---|---|---|---|---|---|---|---|---|
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 1 | February 1, 2001 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 1 | February 1, 2001 | 0 | 0 | 0 | api.fda.gov |
| Modern Medical Equipment Manufacturing, Ltd. | Kwai Chung, N.T., Hong Kong | Exporter to the US, Manufacturer | 1 | May 19, 2010 | 0 | 0 | 0 | api.fda.gov |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing (qing Yuan) Ltd | QING YUAN Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing Ltd. | HENG LI, DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Morris Medical Inc. | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rocamed Sam | MONACO Monaco-Ville, Monaco | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 19, 2010. 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.