Data / Medical devices / United States / Burton Medical LLC
Burton Medical LLC: FDA-registered device maker in Addison, IL, United States, 3 510(k) clearances
Burton Medical LLC is registered with the FDA (registration 3009542956) in Addison, IL, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 30, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009542956
- Address
- 2300 W Windsor Ct. STE C, Addison, IL, United States, 60101
- Owner or operator
- Burton Medical LLC (10040558)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- April 24, 2012
- Registered through
- 2026
- Brand names listed
- "GENIE' SINGLE CEILING AND DOUBLE CEILING, AIM 100 MINOR SURGERY LIGHT, AIM 200, MAJOR SURGICAL LIGHT, AIM 50, AIM LED, APEX, APEX LED, CoolSpot II and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Medical Examination, Ac Powered | KZF | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Headlamp, Operating, Battery-Operated | HPP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Light, Surgical, Ceiling Mounted | FSY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Light, Surgical, Floor Standing | FSS | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 30, 2010 | K101537 | AIM 200, MAJOR SURGICAL LIGHT | FSY | Substantially Equivalent | Burton Medical Products Corp. | accessdata.fda.gov |
| December 1, 2004 | K042395 | OUTPATIENT III MINOR SURGERY LIGHT | FSY | Substantially Equivalent | Burton Medical Products Corp. | accessdata.fda.gov |
| November 13, 1996 | K963682 | GENIE' SINGLE CEILING AND DOUBLE CEILING | FSY | Substantially Equivalent | Burton Medical Products Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Surgical, Ceiling Mounted
- All makers of Headlamp, Operating, Battery-Operated
- All makers of Device, Medical Examination, Ac Powered
- All makers of Light, Surgical, Floor Standing
Updated September 30, 2010. 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.