FDA applicant

Foundation Medicine, Inc.

Cambridge5 decisions2016–202010 recalls

FDA records 5 decisions for Foundation Medicine, Inc. (Cambridge) from 2016 to 2020: 5 original PMA approvals. All are in product code PQP (Next Generation Sequencing Oncology Panel…). 10 recalls are linked to its devices.

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

FIG. A — Illustration, pathology panel, where it files most

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

FDA decisions per year

3in 2020

2016high 3 (2020) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

3in 2026

2016high 3 (2026) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Foundation Medicine, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Foundation”

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

Foundation Surgical Group, Inc. 5 Foundation Fusion Solutions, LLC (Dba Cornerloc) 2 Foundation Milling Centre 1 Foundation For Fluency, Inc. 1

Foundation Medicine, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Foundation”