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Ostex Intl., Inc.

FDA Regulatory Profile

Ostex Intl., Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 30, 2001.

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K011052OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USEJuly 30, 2001
K983457OSTEOMARK NTX SERUM EIAFebruary 2, 1999
K980518OSTEOMARKMarch 6, 1998
K961562OSTEOMARKJuly 11, 1996
K945946OSTEOMARK(R)May 8, 1995

FDA data resources