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Hexcel Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K840416HEXCELITEMarch 23, 1984
K820890URETHANE ORTHOPAEDIC CASTING TAPEJune 23, 1982
K812687BRIGHAM II TOTAL HIP SYSTEMOctober 2, 1981
K812669SEATTLE II TOTAL HIP SYSTEMOctober 2, 1981
K812068PROPOSED CONTROLS FOR DOSIMETRIC RELEASESeptember 8, 1981
K811164URETHANE ORTHOPAEDIC CASTING TAPEMay 27, 1981
K810957MARCOVE INTRAMEDULLARY RODApril 17, 1981
K810956MARCOVE HUMERAL RODApril 17, 1981
K810230CONDYLAR KNEE W/METAL ENCAPSULATED TIBMarch 6, 1981
K800051HEXCEL FEMORAL COMPONENT HIP PROSTHESISJanuary 28, 1980
K800050ANITOMIC TOTAL HIP SYSTEMJanuary 24, 1980
K781971KNEE SYSTEM, QUADRAXIAL CONSTRAINEDApril 4, 1979
K760841HEXCELITE SHEET SPLINTSNovember 1, 1976