510(k) Report

FDA applicant

Bridger Biomed, Inc.

Bozeman, MT7 decisions1997–20010 recalls

FDA records 7 decisions for Bridger Biomed, Inc. (Bozeman, MT) from 1997 to 2001: 7 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Bridger Biomed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bridger Biomed, 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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