Panels › General, Plastic Surgery › Product code FYH · Class 1
Splint, Extremity, Noninflatable, External, Sterile
Regulation 878.3910
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FYH
| Company | 510(k)s | Recalls |
|---|---|---|
| Johnson & Johnson Professionals, Inc. | 2 | 0 |
| Compression Splint Products, Inc. | 1 | 0 |
| The Huxley Instrument Corp. | 1 | 0 |
| Johnson & Johnson Orthopaedics, Inc. | 1 | 0 |
| Kut-Guard, Inc. | 1 | 0 |
| Orthopedic Systems, Inc. | 1 | 0 |
| Trace Medical Equipment, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 1993 | K925145 | TRACE MODEL #'S 840, 841, 842, 845 Trace Medical Equipment, Inc. | FYH |
| Feb 1, 1993 | K924984 | SPECIALIST(R) WALKER Johnson & Johnson Orthopaedics, Inc. | FYH |
| Sep 26, 1989 | K895092 | KUT-SHIELD Kut-Guard, Inc. | FYH |
| Jul 2, 1985 | K852558 | SPLINTS(ALL TYPE) The Huxley Instrument Corp. | FYH |
| Oct 24, 1984 | K843400 | HYDRO-SPLINT A SPONGE-COMPRESS DRESS Compression Splint Products, Inc. | FYH |
| Jul 2, 1982 | K821693 | J & J DIP WATER ADDITIVE Johnson & Johnson Professionals, Inc. | FYH |
| Jan 8, 1981 | K802522 | DELTA-LITE CASTING TAPE & SPLINTS Johnson & Johnson Professionals, Inc. | FYH |
| Jun 26, 1980 | K801436 | ORTHOPEDIC LOWER EXTREMITY SUSPENSION Orthopedic Systems, Inc. | FYH |
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