Data / Medical devices / United States / Lighthouse For The Blind
Lighthouse For The Blind: FDA-registered device maker in Saint Louis, MO, United States, 1 510(k) clearance
Lighthouse For The Blind is registered with the FDA (registration 1925025) in Saint Louis, MO, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 24, 2005. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1925025
- FEI number
- 1000118065
- Address
- 10440 Trenton Ave., Saint Louis, MO, United States, 63132
- Owner or operator
- LIGHTHOUSE FOR THE BLIND (9004139)
- Roles
- Repackager or relabeler
- First device listed
- December 27, 2007
- Registered through
- 2026
- Brand names listed
- No Proprietary Name, Oxyband, Type 1, Type III, Type IV, UltraFlex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Body Fluids Barrier Kit | OKH | 2 | Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wound Dressings Containing Oxygen | SIL | U | 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 |
|---|---|---|---|---|---|---|
| March 24, 2005 | K043063 | OXYBAND WOUND DRESSING | SIL | Substantially Equivalent | Oxyband Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 22, 2013 | 64776 | Class III | Terminated | LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit. | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cu | accessdata.fda.gov |
Compare with other makers
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
- All makers of First Aid Kit Without Drug
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Body Fluids Barrier Kit
- All makers of First Aid Kit With Drug
Updated April 10, 2013. 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.