510(k) Report

FDA applicant

Telectronics, Inc.

Mchenry, IL108 decisions1977–19900 recalls

FDA records 108 decisions for Telectronics, Inc. (Mchenry, IL) from 1977 to 1990: 107 510(k) clearances and 1 original PMA approval. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and DTB (Permanent Pacemaker Electrode). 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 Telectronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Telectronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Telectronics, 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 “Telectronics”

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