FDA applicant

Bremer Mfg. & Tool Co., Inc.

Winter Park, FL1 decision1989–19890 recalls

FDA records 1 decision for Bremer Mfg. & Tool Co., Inc. (Winter Park, FL) in 1989: 1 510(k) clearance. All are in product code LGH (Instrument, Cast Removal, Ac-Powered). 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, orthopedic panel, where it files most

How often FDA has decided Bremer Mfg. & Tool Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bremer Mfg. & Tool Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bremer Mfg. & Tool Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Bremer”

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

Bremer Medical, Inc. 2 Bremer Orthopedics 1

Bremer Mfg. & Tool Co., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bremer”