Light, Surgical Headlight
Regulation 872.4630
0510(k)s in 12 months (10 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in EBA
| Company | 510(k)s | Recalls |
|---|---|---|
| Orascoptic Surgical Acuity | 0 | 4 |
| Harry J. Bosworth Co. | 2 | 0 |
| Alpine Dental Equipment Co. | 1 | 0 |
| Colmed, Ltd. | 1 | 0 |
| Cuda Products Co. | 1 | 0 |
| Good-Lite Co. | 1 | 0 |
| Kelleher Corp. | 1 | 0 |
| Kerr Corporation | 0 | 1 |
| Photonic Optische Gerate GmbH & Cokg | 1 | 0 |
| Planmeca USA, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Phantom Nose Pad Accessory Kit ( nose pad and screw)
1 pk. and 20 pk. Open, Classified |
EBA | None listed |
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) Open, Classified |
EBA | None listed |
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) Open, Classified |
EBA | None listed |
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Custom loupes configured with Phantom Frames Open, Classified |
EBA | None listed |
| Nov 20, 2012 | Kerr Corporation Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 7700100 Terminated |
EBA | None listed |
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