LBL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tube, Tympanostomy, Porous Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3880
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
- Adverse events (MAUDE)
- 1996: 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 |
|---|---|---|
| J&S HDL CHOLESTEROL PRECIPITATING REAGENT (K900218) | J.S. Medical Assoc. | 1990-06-18 |
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Every clearance here is in the API, with alerts when new ones post.