510(k) Report

FDA applicant

Frigitronics of Connecticut, Inc.

Walker, MI9 decisions1976–19890 recalls

FDA records 9 decisions for Frigitronics of Connecticut, Inc. (Walker, MI) from 1976 to 1989: 9 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and HQE (Instrument, Vitreous Aspiration And Cutting…). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Frigitronics of Connecticut, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Frigitronics of Connecticut, 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 “Frigitronics”

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