HOB
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Clamp, Muscle, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EYE SURGERY INSTRUMENT (K840101) | Truline Instruments, Inc. | 1984-03-16 |
| CATEGORY 6 OPTHALMIC DEVICES (K840310) | Imm Enterprises , Ltd. | 1984-03-16 |
| CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC (K780851) | Varian Assoc., Inc. | 1978-06-30 |
Track HOB automatically
Every clearance here is in the API, with alerts when new ones post.