FDA applicant

Electro-Nucleonics, Inc.

Columbia, MD9 decisions1988–19891 recall

FDA records 9 decisions for Electro-Nucleonics, Inc. (Columbia, MD) from 1988 to 1989: 9 510(k) clearances. Most are in product codes GQO (Antisera, Cf, Herpesvirus Hominis 1,2) and CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt). 1 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, microbiology panel, where it files most

How often FDA has decided Electro-Nucleonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Electro-Nucleonics, Inc. since 2007.

Recalls per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Electro-Nucleonics, 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 “Electro-Nucleonics”

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

Electro-Nucleonics Laboratories, Inc. 41 Electro-Catheter Corp. 35 Electro-Biology, Inc. 28 Electro Medical Systems SA 11 Electro Therapeutic Devices, Inc. 8 Electro Med Supply, Inc. 8 Electro-Med Health Industries, Inc. 6 Electro-Diagnostic Instruments 4 Electro Medical Systems (Ems Sa) 3 Electro Fiberoptics Corp. 3 Electro-Cap Intl., Inc. 3 Electro-Diagnostic Imaging, Inc. 2

Electro-Nucleonics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Electro-Nucleonics”