510(k) Report

FDA applicant

Browne Medical, Inc.

Walker, MI4 decisions1983–19850 recalls

FDA records 4 decisions for Browne Medical, Inc. (Walker, MI) from 1983 to 1985: 4 510(k) clearances. Most are in product codes FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…) and FFG (Device, Urine Flow Rate Measuring…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Browne 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 “Browne”

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