510(k) Report

FDA applicant

Bremer Medical, Inc.

Washington, DC2 decisions1992–199315 recalls

FDA records 2 decisions for Bremer Medical, Inc. (Washington, DC) from 1992 to 1993: 2 510(k) clearances. Most are in product codes HAX (Tong, Skull For Traction) and JEC (Component, Traction, Invasive). 15 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Bremer Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bremer Medical, 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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Other applicant names beginning “Bremer”

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