FDA applicant
Telectronics, Inc.
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
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.
Planning a device like Telectronics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Telectronics”
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