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Gynex Corp.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K061306
CO-1000 COLPOSCOPE, MULTIPLE
August 7, 2006
K982739
GYNEX ELECTRODES
March 12, 1999
K980238
GYNEX EXTENDED REACH NEEDLE
August 21, 1998
K980237
GYNEX ENDOSPECULUM
April 8, 1998
K980247
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
March 17, 1998