Home › Device types › EBA
Light, Surgical Headlight
FDA product code EBA · Class 1 · Dental
276
Registered devices
15
Adverse events
5
Recalls
10
510(k) clearances
Devices with this code
Endeavour™ MD — METREX RESEARCH, LLCBlack & Black Surgical — BLACK & BLACK SURGICAL, INC.Endeavour™ TruColor™ XL — METREX RESEARCH, LLCEndeavour™ TruColor™ — METREX RESEARCH, LLCN/A — BLACK & BLACK SURGICAL, INC.Spark™ TruColor™ — METREX RESEARCH, LLCBlack & Black Surgical — BLACK & BLACK SURGICAL, INC.N/A — BLACK & BLACK SURGICAL, INC.Endeavour™ TruColor™ — METREX RESEARCH, LLCEndeavour™ TruColor™ — METREX RESEARCH, LLCOrascoptic - Endeavour Headlight System — METREX RESEARCH, LLCSpark™ TruColor™ — METREX RESEARCH, LLCOrascoptic - Endeavour TruColor Headlight System — METREX RESEARCH, LLCEndeavour™ TruColor™ — METREX RESEARCH, LLCOrascoptic - Endeavour XL Headlight System — METREX RESEARCH, LLCSpark™ TruColor™ — METREX RESEARCH, LLCSpark™ TruColor™ — METREX RESEARCH, LLCSpark™ TruColor™ — METREX RESEARCH, LLCEndeavour™ TruColor™ — METREX RESEARCH, LLCOrascoptic - Endeavour TruColor Headlight System — METREX RESEARCH, LLCOrascoptic - Endeavour Headlight System — METREX RESEARCH, LLCOrascoptic - Spark TruColor Headlight System — METREX RESEARCH, LLCSpark™ TruColor™ — METREX RESEARCH, LLCOrascoptic - Endeavour Headlight System — METREX RESEARCH, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2011-11-17 | Kerr Corporation | The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cau |
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