FDA applicant

Novacor Div.

Flemington, NJ1 decision2000–20000 recalls

FDA records 1 decision for Novacor Div. (Flemington, NJ) in 2000: 1 510(k) clearance. All are in product code MLO (Electrocardiograph, Ambulatory, With Analysis…). Its devices cite 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Novacor Div. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Novacor”

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

Novacor 2 Novacor France 1

Novacor Div.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Novacor”