FDA applicant

Bioform, Inc.

Franksville, WI4 decisions2001–20031 recall

FDA records 4 decisions for Bioform, Inc. (Franksville, WI) from 2001 to 2003: 4 510(k) clearances. Most are in product codes MIX (System, Vocal Cord Medialization) and NEU (Marker, Radiographic, Implantable). Its devices cite 18 predicates, 2 of them its own earlier devices. 1 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Bioform, Inc. since 2007.

Recalls per year

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Bioform, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Bioform”

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

Bioform Medical, Inc. 3

Bioform, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Bioform”