510(k) Report

FDA applicant

Ttj Biomedical, LLC

Boulder, CO1 decision2001–20010 recalls

FDA records 1 decision for Ttj Biomedical, LLC (Boulder, CO) in 2001: 1 510(k) clearance. All are in product code MQF (Catheter, Assisted Reproduction). 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 Ttj Biomedical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ttj Biomedical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MQFCatheter, Assisted Reproduction1decision

What has FDA decided for it lately?

  • K012220Tao Embryo Transfer Catheter SystemTtj Biomedical, LLC · 2001

The one decision as Ttj Biomedical, LLC →