Company ยท US
Bioteque America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2004. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 2004 | K041094 | HSG CATHETER SET Bioteque America, Inc. | LKF |
| May 24, 2002 | K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 Bioteque America, Inc. | HHK |
| Dec 27, 2001 | K013289 | BIOTEQUE VAGINAL PESSARIES Bioteque America, Inc. | HHW |
| Jan 29, 2001 | K003380 | BIOTEQUE VAGINAL DILATOR Bioteque America, Inc. | HDX |
| Nov 8, 1995 | K920633 | PESSARY FLEXIBLE SILICONE NICHOLS Bioteque America, Inc. | KXP |
| Aug 29, 1994 | K920747 | PESSARY FLEXIBLE SILICONE DONUT RING Bioteque America, Inc. | HHW |
| Mar 11, 1994 | K933628 | CYTOLOGY BRUSH Bioteque America, Inc. | HHT |
| Mar 7, 1994 | K933521 | SPECULUM Bioteque America, Inc. | HIB |
| Oct 23, 1992 | K920187 | FLEXIBLE SILICONE GELIHORN Bioteque America, Inc. | HHW |
| Jul 13, 1992 | K920177 | VERSA-VIAL Bioteque America, Inc. | DQF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2005 | Bioteque America Inc Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch Terminated |
None listed |