KYC
3 FDA 510(k) clearances · Product code
FDA profile
- Adverse events (MAUDE)
- 1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| FLUORETS STERILE OPHTH. STRIPS (K831621) | Smith & Nephew, Inc. | 1983-07-18 | + Add |
| BARNES-HIND ROSE BENGAL OPHTHALMIC STR. (K810285) | Barnes-Hind, Inc. | 1981-04-17 | + Add |
| FLUORESOFT (K780125) | Holles Laboratories, Inc. | 1978-03-15 | + Add |
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Every clearance here is in the API, with alerts when new ones post.