FDA applicant

Biotronik Cardiac Pacemakers

Lake Oswego, CA3 decisions1989–19900 recalls

FDA records 3 decisions for Biotronik Cardiac Pacemakers (Lake Oswego, CA) from 1989 to 1990: 3 510(k) clearances. All are in product code DXY (Implantable Pacemaker Pulse-Generator). 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 Cardiac Pacemakers’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotronik Cardiac Pacemakers since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biotronik Cardiac Pacemakers by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biotronik Cardiac Pacemakers’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 Sales, Inc. 41 Biotronik Nro, Inc. 1

Biotronik Cardiac Pacemakers

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biotronik”