Medical Device Manufacturer · US , San Antonio , TX

Biomedical Enterprises, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2002

Recent clearances: Converge, Elite Nitinol Fixation System, Nitinol Compression Plating System

View 10 510(k) Devices ↓

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biomedical Enterprises, Inc. Orthopedic ✕

10 devices

1-10 of 10

Cleared Aug 11, 2016

Orthopedic · 240d

Cleared May 11, 2015

Elite Nitinol Fixation System

Orthopedic · 111d

Cleared Jan 16, 2015

Nitinol Compression Plating System

Orthopedic · 87d

Cleared Nov 17, 2014

Speed, Speed Shift, Speed Titan, Speed Arc

Orthopedic · 91d

Cleared Apr 17, 2014

Orthopedic · 176d

Cleared Jan 09, 2014

Orthopedic · 55d

Cleared May 14, 2013

Orthopedic · 137d

Cleared May 30, 2007

OSSTAPLE, OSSPLATE, OSSFORCE

Orthopedic · 377d

Cleared Oct 31, 2002

OSSTAPLE, MAXILLOFACIAL

Orthopedic · 14d

Cleared Oct 31, 2002

OSSTAPLE, CRANIOFACIAL

Orthopedic · 14d