Company ยท US
Hexcel Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1984. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ITG | Bandage, Cast | 4 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 1 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 1984 | K840416 | HEXCELITE Hexcel Medical | ITG |
| Jun 23, 1982 | K820890 | URETHANE ORTHOPAEDIC CASTING TAPE Hexcel Medical | ITG |
| Oct 2, 1981 | K812687 | BRIGHAM II TOTAL HIP SYSTEM Hexcel Medical | JDG |
| Oct 2, 1981 | K812669 | SEATTLE II TOTAL HIP SYSTEM Hexcel Medical | JDG |
| Sep 8, 1981 | K812068 | PROPOSED CONTROLS FOR DOSIMETRIC RELEASE Hexcel Medical | LIB |
| May 27, 1981 | K811164 | URETHANE ORTHOPAEDIC CASTING TAPE Hexcel Medical | ITG |
| Apr 17, 1981 | K810957 | MARCOVE INTRAMEDULLARY ROD Hexcel Medical | HSB |
| Apr 17, 1981 | K810956 | MARCOVE HUMERAL ROD Hexcel Medical | HSB |
| Mar 6, 1981 | K810230 | CONDYLAR KNEE W/METAL ENCAPSULATED TIB Hexcel Medical | HRY |
| Jan 28, 1980 | K800051 | HEXCEL FEMORAL COMPONENT HIP PROSTHESIS Hexcel Medical | JDG |
| Jan 24, 1980 | K800050 | ANITOMIC TOTAL HIP SYSTEM Hexcel Medical | JDG |
| Apr 4, 1979 | K781971 | KNEE SYSTEM, QUADRAXIAL CONSTRAINED Hexcel Medical | KRO |
| Nov 1, 1976 | K760841 | HEXCELITE SHEET SPLINTS Hexcel Medical | ITG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||