Data / Medical devices / United States / Noreaster Medical LLC
Noreaster Medical LLC: FDA-registered device maker in Lincoln, RI, United States, 2 510(k) clearances
Noreaster Medical LLC is registered with the FDA (registration 3010709436) in Lincoln, RI, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 8, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010709436
- Address
- 2 Pine Grove Ave, Lincoln, RI, United States, 02865
- Owner or operator
- Nor'easter Medical LLC (10061962)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 6, 2019
- Registered through
- 2026
- Brand names listed
- Bristle, VeinGogh
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical Coagulation For Aesthetic | ONQ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 8, 2012 | K112334 | VEIN-GOGH INSTRUMENT | ONQ | Substantially Equivalent | Refine USA, LLC | accessdata.fda.gov |
| April 2, 2012 | K112426 | XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES | ETN | Substantially Equivalent | Xian Friendship Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 8, 2012. 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.