Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Bioteque America with 10 510(k) clearances. The most recent is a 510(k) clearance dated Jun 17, 2004: HSG CATHETER SET.
| Jun 17, 2004 | HSG CATHETER SETK041094 · LKF | 510(k) clearances |
| May 24, 2002 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5K020628 · HHK | 510(k) clearances |
| Dec 27, 2001 | BIOTEQUE VAGINAL PESSARIESK013289 · HHW | 510(k) clearances |
| Jan 29, 2001 | BIOTEQUE VAGINAL DILATORK003380 · HDX | 510(k) clearances |
| Nov 8, 1995 | PESSARY FLEXIBLE SILICONE NICHOLSK920633 · KXP | 510(k) clearances |
| Aug 29, 1994 | PESSARY FLEXIBLE SILICONE DONUT RINGK920747 · HHW | 510(k) clearances |
| Mar 11, 1994 | CYTOLOGY BRUSHK933628 · HHT | 510(k) clearances |
| Mar 7, 1994 | SPECULUMK933521 · HIB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
