Data / Medical devices / Wound Cleaner, Ultrasound
Wound Cleaner, Ultrasound (NRB): 6 FDA-registered makers in 1 country
6 establishments in 1 country are registered with the FDA to make Wound Cleaner, Ultrasound (product code NRB, Class 2, 21 CFR 878.4410). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on December 22, 2016, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NRB
- Device class
- 2
- Regulation
- 878.4410
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
Makers of Wound Cleaner, Ultrasound
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 |
|---|---|---|---|---|---|---|---|---|
| Arobella Medical, LLC | Minnetonka, MN, United States | Manufacturer | 2 | May 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| Misonix, LLC | Farmingdale, NY, United States | Complaint file establishment, Manufacturer | 2 | March 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Sanuwave, Inc. | Eden Prairie, MN, United States | Manufacturer, Repackager or relabeler | 1 | August 13, 2014 | 0 | 0 | 0 | api.fda.gov |
| Donatelle Plastics, LLC | New Brighton, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynamic Group | Ramsey, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 22, 2016. 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.