FDA applicant

Biotronik Sales, Inc.

Mchenry, IL41 decisions1980–19880 recalls

FDA records 41 decisions for Biotronik Sales, Inc. (Mchenry, IL) from 1980 to 1988: 41 510(k) clearances. 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 Biotronik Sales, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotronik Sales, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biotronik Sales, 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 “Biotronik”

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

Biotronik, Inc. 115 Biotronik Cardiac Pacemakers 3 Biotronik Nro, Inc. 1

Biotronik Sales, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biotronik”