Data / Medical devices / Apparatus, Suction, Patient Care
Apparatus, Suction, Patient Care (DWM): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Apparatus, Suction, Patient Care (product code DWM, Class 2, 21 CFR 870.5050). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on March 3, 2023, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DWM
- Device class
- 2
- Regulation
- 870.5050
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 3 |
| Mexico | 2 |
| United Kingdom | 1 |
| Dominican Republic | 1 |
Makers of Apparatus, Suction, Patient Care
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 |
|---|---|---|---|---|---|---|---|---|
| Bearpac Medical, LLC | Moultonborough, NH, United States | Manufacturer, Specification developer | 2 | November 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Carefusion 2200, Inc. | Vernon Hills, IL, United States | Complaint file establishment, Specification developer | 2 | October 31, 2016 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 2 | March 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| PFM Medical, Inc | Carlsbad, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | November 6, 2009 | 0 | 1 | 0 | api.fda.gov |
| Rocket Medical Plc | WASHINGTON Sunderland, United Kingdom | Manufacturer | 1 | February 1, 2013 | 0 | 0 | 0 | api.fda.gov |
| Alleva Medical (D.G.) Ltd | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Reynosa S.A. De C.V. | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carefusion 2200, Inc. | Mannford, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CareFusion D.R. 203 Ltd. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Chibanda Imp &exp Co, Ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnxon Precision Co., Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 3, 2023. 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.