Medical Device Manufacturer · US , San Antonio , TX

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

13 submissions · 13 cleared · Since 1996

Recent clearances: SPEED TRIAD, SPEED XL, SMOOTH OR THREADED METALLIC BONE FASTENER

View 13 510(k) Devices ↓

13

Total

13

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Apr 07, 2014

Orthopedic · 110d

Cleared Mar 19, 2014

Orthopedic · 97d

Cleared Oct 16, 2013

SMOOTH OR THREADED METALLIC BONE FASTENER

Orthopedic · 134d

Cleared Sep 03, 2010

Orthopedic · 38d

Cleared Feb 19, 2010

Orthopedic · 233d

Cleared Oct 17, 2002

Orthopedic · 22d

Cleared Mar 13, 2001

Orthopedic · 319d

Cleared Feb 25, 2000

MEMOGRAPH STAPLE, WARM SYSTEM

Orthopedic · 115d