Medical Device Manufacturer · US , Waukegan , IL

Care Fusion - FDA 510(k) Cleared Devices

34 submissions · 29 cleared · Since 2010

Recent clearances: BD SmartSite™ 13mm Vial Access Device, BD Texium™ Needle-Free Syringe, BD Alaris™ Pump Epidural Infusion Set

34

Total

29

Cleared

0

Denied

FDA 510(k) Regulatory Record - Care Fusion Orthopedic ✕

6 devices

1-6 of 6

Cleared Nov 24, 2015

AVAflex Vertebral Balloon System

Orthopedic · 210d

Cleared Oct 29, 2015

AVAmax Vertebral Balloon

Orthopedic · 241d

Cleared Oct 04, 2013

AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G,...

Orthopedic · 106d

Cleared Oct 03, 2013

AVAFLEX VERTEBRAL BALLOON SYSTEM

Orthopedic · 105d

Cleared Jan 10, 2011

AVAMAX VERTEBRAL BALLOON

Orthopedic · 84d

Cleared Feb 26, 2010

AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020

Orthopedic · 112d