FDA applicant

Nycomed Pharma AS

N-40401 Oslo 4, Norway, NO1 decision1993–19930 recalls

FDA records 1 decision for Nycomed Pharma AS (N-40401 Oslo 4, Norway, NO) in 1993: 1 510(k) clearance. All are in product code GJS (Test, Time, Prothrombin). 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, hematology panel, where it files most

How often FDA has decided Nycomed Pharma AS’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nycomed Pharma AS since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nycomed Pharma AS’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 “Nycomed”

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

Nycomed Amersham Imaging 1

Nycomed Pharma AS

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Nycomed”