FDA applicant

Nyu Langone Medical Center

New York, NY1 decision2021–20210 recalls

FDA records 1 decision for Nyu Langone Medical Center (New York, NY) in 2021: 1 510(k) clearance. All are in product code PZM (Next Generation Sequencing Based Tumor…). 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, pathology panel, where it files most

How often FDA has decided Nyu Langone Medical Center’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Nyu Langone Medical Center by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nyu Langone Medical Center’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

Nyu Langone Medical Center

Which product codes does it file in?

What has FDA decided for it lately?