FDA applicant

Bio2 Technologies, Inc.

Woburn, MA3 decisions2014–20160 recalls

FDA records 3 decisions for Bio2 Technologies, Inc. (Woburn, MA) from 2014 to 2016: 3 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and HTY (Pin, Fixation, Smooth). Its devices cite 8 predicates, 1 of them its own earlier devices. 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, orthopedic panel, where it files most

How often FDA has decided Bio2 Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014high 1 (2014) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Bio2 Technologies, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bio2 Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Bio2”

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

Bio2 Medical, Inc. 1

Bio2 Technologies, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bio2”