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Hemedex Incorporated
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K141869
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
October 10, 2014
K032127
HEMEDEX FIXATION DEVICE
December 30, 2003
K032337
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
October 21, 2003
K013376
QFLOW 500 PERFUSION MONITORING SYSTEM
May 8, 2002