Bioteque America, Inc. is one of 25175 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bioteque America, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HSG CATHETER SET, CURELLE, PREFERRED CURELLE, CUTEQ 2.5, BIOTEQUE VAGINAL PESSARIES
10
Total
10
Cleared
0
Denied
Bioteque America, Inc. has 10 FDA 510(k) cleared obstetrics & gynecology devices. Based in Levittown, US.
Historical record: 10 cleared submissions from 1992 to 2004.
Browse the complete list of FDA 510(k) cleared obstetrics & gynecology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Citech as regulatory consultant.
FDA 510(k) Regulatory Record - Bioteque America, Inc.
10 devices
Cleared
Jun 17, 2004
HSG CATHETER SET
Obstetrics & Gynecology
51d
Cleared
May 24, 2002
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
Obstetrics & Gynecology
87d
Cleared
Dec 27, 2001
BIOTEQUE VAGINAL PESSARIES
Obstetrics & Gynecology
86d
Cleared
Jan 29, 2001
BIOTEQUE VAGINAL DILATOR
Obstetrics & Gynecology
90d
Cleared
Nov 08, 1995
PESSARY FLEXIBLE SILICONE NICHOLS
Obstetrics & Gynecology
1365d
Cleared
Aug 29, 1994
PESSARY FLEXIBLE SILICONE DONUT RING
Obstetrics & Gynecology
922d
Cleared
Mar 11, 1994
CYTOLOGY BRUSH
Obstetrics & Gynecology
227d
Cleared
Mar 07, 1994
SPECULUM
Obstetrics & Gynecology
230d
Cleared
Oct 23, 1992
FLEXIBLE SILICONE GELIHORN
Obstetrics & Gynecology
283d
Cleared
Jul 13, 1992
VERSA-VIAL
General Hospital
181d