Medical Device Manufacturer · US , Hopkonton , MA

Hemedex Incorporated - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2002

Recent clearances: QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hemedex Incorporated Neurology ✕

2 devices

1-2 of 2

Cleared Oct 10, 2014

QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT

Neurology · 91d

Cleared Oct 21, 2003

HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

Neurology · 84d