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Biostable Science & Engineering, Inc.

FDA Regulatory Profile

Biostable Science & Engineering, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 10, 2017.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K171431HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 AortAugust 10, 2017
K163608HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 AortMarch 21, 2017

FDA data resources