Biostable Science & Engineering, Inc. is one of 19478 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biostable Science & Engineering, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm, HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
2
Total
2
Cleared
0
Denied
Biostable Science & Engineering, Inc. has 2 FDA 510(k) cleared medical devices. Based in Austin, US.
Historical record: 2 cleared submissions from 2017 to 2017. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Biostable Science & Engineering, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Biostable Science & Engineering, Inc.
2 devices