FYH
8 FDA 510(k) clearances · Product code
55 daysmedian time to decision
218 days90th percentile
8clearances measured
FDA profile
- Official device name
- Splint, Extremity, Noninflatable, External, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.3910
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1999: 1 · 2000: 2 · 2001: 2 · 2002: 3 · 2003: 6 · 2008: 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 |
|---|---|---|
| TRACE MODEL #'S 840, 841, 842, 845 (K925145) | Trace Medical Equipment, Inc. | 1993-05-19 |
| SPECIALIST(R) WALKER (K924984) | Johnson & Johnson Orthopaedics, Inc. | 1993-02-01 |
| KUT-SHIELD (K895092) | Kut-Guard, Inc. | 1989-09-26 |
| SPLINTS(ALL TYPE) (K852558) | The Huxley Instrument Corp. | 1985-07-02 |
| HYDRO-SPLINT A SPONGE-COMPRESS DRESS (K843400) | Compression Splint Products, Inc. | 1984-10-24 |
| J & J DIP WATER ADDITIVE (K821693) | Johnson & Johnson Professionals, Inc. | 1982-07-02 |
| DELTA-LITE CASTING TAPE & SPLINTS (K802522) | Johnson & Johnson Professionals, Inc. | 1981-01-08 |
| ORTHOPEDIC LOWER EXTREMITY SUSPENSION (K801436) | Orthopedic Systems, Inc. | 1980-06-26 |
Track FYH automatically
Every clearance here is in the API, with alerts when new ones post.