Panels › Ophthalmic › Product code FSR · Class 2
Light, Headband, Surgical
Regulation 886.4335
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FSR
| Company | 510(k)s | Recalls |
|---|---|---|
| Welch Allyn, Inc. | 2 | 0 |
| Angiolaz, Inc. | 1 | 0 |
| Integra LifeSciences Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 11, 2011 | K110528 | INTEGRA LED SURGICAL HEADLIGHT SYSTEM Integra LifeSciences Corporation | FSR |
| Aug 11, 2003 | K031549 | SOLID STATE LAMP [LED] HEADLIGHT Welch Allyn, Inc. | FSR |
| Aug 11, 2003 | K031548 | LED HEADLIGHT Welch Allyn, Inc. | FSR |
| May 11, 2000 | K994362 | HEADLAMP HL2000. Angiolaz, Inc. | FSR |
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