Data / Medical devices / United States / Fulwell LLC
Fulwell LLC: FDA-registered device maker in Miami, FL, United States, 4 510(k) clearances
Fulwell LLC is registered with the FDA (registration 3010131466) in Miami, FL, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 13, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010131466
- Address
- 3411 NW 48 Street, Miami, FL, United States, 33142
- Owner or operator
- Fulwell LLC (10043857)
- Roles
- Repackager or relabeler
- First device listed
- March 29, 2013
- Registered through
- 2026
- Brand names listed
- Electrode, electrocardiograph, Electrosurgical, cutting & coagulation & accessories, FORCEPS, BIOPSY, NON-ELECTRIC, Face Mask Within the Scope of the Face Mask and Barrier Face Covering Enforcement Policy or Face Mask Umbrella EUA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 13, 2019 | K183564 | Electrosurgical Generator | GEI | Substantially Equivalent | Fulwell, LLC | accessdata.fda.gov |
| January 30, 2017 | K162034 | OBS Electrosurgical Generator (Model: OBS-350A) | GEI | Substantially Equivalent | Baisheng Medical Co., Ltd. | accessdata.fda.gov |
| November 3, 2010 | K102372 | OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB | GEI | Substantially Equivalent | Jiangmen City Xinhui Baisheng Medical Equipment CO | accessdata.fda.gov |
| December 1, 2009 | K092634 | OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF | GEI | Substantially Equivalent | Jiangmen City Xinhui Baisheng Medical Equipment CO | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Electrode, Electrocardiograph
Updated June 13, 2019. 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.