Bioteque America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K041094HSG CATHETER SETJune 17, 2004
K020628CURELLE, PREFERRED CURELLE, CUTEQ 2.5May 24, 2002
K013289BIOTEQUE VAGINAL PESSARIESDecember 27, 2001
K003380BIOTEQUE VAGINAL DILATORJanuary 29, 2001
K920633PESSARY FLEXIBLE SILICONE NICHOLSNovember 8, 1995
K920747PESSARY FLEXIBLE SILICONE DONUT RINGAugust 29, 1994
K933628CYTOLOGY BRUSHMarch 11, 1994
K933521SPECULUMMarch 7, 1994
K920187FLEXIBLE SILICONE GELIHORNOctober 23, 1992
K920177VERSA-VIALJuly 13, 1992