FDA applicant

Harvard Apparatus, Inc.

Mchenry, IL9 decisions1978–19982 recalls

FDA records 9 decisions for Harvard Apparatus, Inc. (Mchenry, IL) from 1978 to 1998: 9 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and FLE (Sterilizer, Steam). 2 recalls are 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Harvard Apparatus, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Harvard Apparatus, 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 “Harvard”

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

Harvard Laboratories 8 Harvard Medical Devices, Ltd. 5 Harvard Clinical Technology 2

Harvard Apparatus, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Harvard”