Medgyn Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0917-2018Class IIMonsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicatoJuly 3, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K143669MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI CatheterNovember 23, 2015
K122973AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPEJune 12, 2013
K945179BOTTLE COLLECTION SETJanuary 26, 1995
K880196LAMINARIAMay 6, 1988
K880195GYNESCOPEMarch 14, 1988