FDA applicant

Biolectron, Inc.

Hackensack, NJ1 decision1997–19970 recalls

FDA records 1 decision for Biolectron, Inc. (Hackensack, NJ) in 1997: 1 510(k) clearance. All are in product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic…). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Biolectron, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biolectron, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?