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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2007 | K070287 | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 Photonic Optische Gerate GmbH & Cokg, AT | EBA |
| Oct 16, 1992 | K923949 | SYLVAN DENTAL HEADLIGHT SYSTEM Sylvan Medical Fiberoptics | EBA |
| Jun 22, 1989 | K893458 | FIBEROPTIC HEADLIGHT SYSTEM Cuda Products Co. | EBA |
| Mar 6, 1986 | K854646 | VEGA DENTAL OPERATING LIGHT Alpine Dental Equipment Co. | EBA |
| Aug 2, 1984 | K842515 | SURGICAL HEADLIGHT Good-Lite Co. | EBA |
| Jul 31, 1984 | K842358 | ISOLIGHT Planmeca USA, Inc. | EBA |
| Sep 28, 1982 | K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS Kelleher Corp. | EBA |
| Feb 10, 1981 | K810117 | HALOGEN HEADLIGHT SYSTEM Colmed, Ltd. | EBA |
| Aug 3, 1979 | K790807 | METALIT Harry J. Bosworth Co. | EBA |
| Aug 3, 1979 | K790806 | PORCELIT Harry J. Bosworth Co. | EBA |
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