510(k) Report

FDA applicant

Broadwest Corp.

New York, NY6 decisions1985–19870 recalls

FDA records 6 decisions for Broadwest Corp. (New York, NY) from 1985 to 1987: 6 510(k) clearances. Most are in product codes IKE (Transducer, Miniature Pressure) and FOX (Stand, Infusion). 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 hospital panel, where it files most

How often FDA has decided Broadwest Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Broadwest Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Broadwest Corp.’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