510(k) Report

FDA applicant

Avery Biomedical Devices, Inc.

Commack2 decisions1982–19870 recalls

FDA records 2 decisions for Avery Biomedical Devices, Inc. (Commack) from 1982 to 1987: 2 original PMA approvals. Most are in product codes LHY (Electrode, Stabilized Epidural Spinal) and GZE (Implanted Diaphragmatic/Phrenic Nerve Stimulator). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Avery Biomedical Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LHYElectrode, Stabilized Epidural Spinal1decision
  • GZEImplanted Diaphragmatic/Phrenic Nerve Stimulator1decision

What has FDA decided for it lately?

  • P860026Diaphragmatic Pacemaker Phrenic Nerve StimulatorAvery Biomedical Devices, Inc. · 1987
  • P810033Spinal Epidural Electrode for P.E.N.S. Model E-355Avery Biomedical Devices, Inc. · 1982

All 2 as Avery Biomedical Devices, Inc. →

Other applicant names beginning “Avery”

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

Avery Intl. 12Avery Dennison Belgie Bvba 5Avery Dennison Medical, Ltd. 1Avery Dennison Corporation 1