DOX
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fluorometer, Lead (Dedicated Instruments)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3550
- Medical specialty
- Clinical Toxicology
- Adverse events (MAUDE)
- 2005: 2
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 |
|---|---|---|
| KAYAK HYDROPHILIC GUIDE WIRES (K014195) | Boston Scientific Corp | 2002-03-19 |
| MSI PROCEDURE KIT (K944226) | Msi, Inc. | 1995-06-21 |
| HYDRO-SIL(TM) COATED GUIDEWIRES (K900822) | National-Standard Medical Products | 1990-07-17 |
| HEPARIN COATED STAINLESS STEEL/TEFLON (K832030) | Argon Medical Corp. | 1983-09-29 |
Track DOX automatically
Every clearance here is in the API, with alerts when new ones post.