Medical Device Manufacturer · US , Levittown , PA

Bioteque America, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1992

Recent clearances: HSG CATHETER SET, CURELLE, PREFERRED CURELLE, CUTEQ 2.5, BIOTEQUE VAGINAL PESSARIES

View 10 510(k) Devices ↓

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bioteque America, Inc. Obstetrics & Gynecology ✕

9 devices

1-9 of 9

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

Obstetrics & Gynecology · 227d

Cleared Mar 07, 1994

Obstetrics & Gynecology · 230d

Cleared Oct 23, 1992

FLEXIBLE SILICONE GELIHORN

Obstetrics & Gynecology · 283d