FDA applicant

Pramand, LLC

Bedford2 decisions2023–20250 recalls

FDA records 2 decisions for Pramand, LLC (Bedford) from 2023 to 2025: 2 original PMA approvals. All are in product code NQR (Sealant, Dural). 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, neurology panel, where it files most

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

FDA decisions per year

1in 2025

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Pramand, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pramand, LLC’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

Pramand, LLC

Which product codes does it file in?

What has FDA decided for it lately?