FDA applicant

Bioteque America, Inc.

Langhorne, PA10 decisions1992–20040 recalls

FDA records 10 decisions for Bioteque America, Inc. (Langhorne, PA) from 1992 to 2004: 10 510(k) clearances. Most are in product codes HHW (Pessary, Vaginal) and HHT (Spatula, Cervical, Cytological). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Bioteque America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioteque America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioteque America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Bioteque”

FDA records each applicant name separately; these may or may not be the same firm.

Bioteque Corp. 14

Bioteque America, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bioteque”