FDA applicant

Cooper Biomedical, Inc.

Malvern, PA19 decisions1983–19870 recalls

FDA records 19 decisions for Cooper Biomedical, Inc. (Malvern, PA) from 1983 to 1987: 19 510(k) clearances. Most are in product codes JJE (Analyzer, Chemistry (Photometric, Discrete)…) and CEK (Biuret (Colorimetric), Total Protein). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Cooper Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Cooper”

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

Cooper Lasersonics, Inc. 54 Cooper-Hewitt Electric Co. 8 Cooper Medical Devices Corp. 7 Cooper Surgical 6 Cooper Medical Corp. 5 Cooper Laboratories 1 Cooper Surgical/Aesthete 1 Cooper Diagnostics, Inc. 1 The Cooper Companies 1

Cooper Biomedical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Cooper”