Data / Medical devices / United States / Visionare LLC
Visionare LLC: FDA-registered device maker in Fort Myers, FL, United States, 1 510(k) clearance
Visionare LLC is registered with the FDA (registration 3011196443) in Fort Myers, FL, United States. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 28, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011196443
- Address
- 12220 ITEC Haul Dr Units 215/216, Fort Myers, FL, United States, 33913
- Owner or operator
- Visionare LLC (10047752)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 3, 2018
- Registered through
- 2026
- Brand names listed
- VISIONARE, Visionare
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Trocar, Ent | KTE | 1 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 28, 2018 | K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | JEY | Substantially Equivalent | Visionare, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Template
- All makers of Guide, Surgical, Instrument
- All makers of Gauge, Depth
- All makers of Clamp
- All makers of Forceps, General & Plastic Surgery
Updated December 28, 2018. 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.