FDA applicant

Collaborative Care Diagnostics, LLC, D.B.A. Biomedix

Eagan, MN1 decision2022–20220 recalls

FDA records 1 decision for Collaborative Care Diagnostics, LLC, D.B.A. Biomedix (Eagan, MN) in 2022: 1 510(k) clearance. All are in product code JOM (Plethysmograph, Photoelectric, Pneumatic Or…). Its devices cite 1 predicate, 0 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, cardiovascular panel, where it files most

How often FDA has decided Collaborative Care Diagnostics, LLC, D.B.A. Biomedix’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Collaborative Care Diagnostics, LLC, D.B.A. Biomedix by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Collaborative”

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

Collaborative Research, Inc. 2

Collaborative Care Diagnostics, LLC, D.B.A. Biomedix

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Collaborative”