FDA applicant

Biotronik Nro, Inc.

Lake Oswego1 decision2023–20230 recalls

FDA records 1 decision for Biotronik Nro, Inc. (Lake Oswego) in 2023: 1 original PMA approval. All are in product code LGW (Stimulator, Spinal-Cord, Totally Implanted For…). 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 Biotronik Nro, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Biotronik Nro, Inc. by year, 2023–2026Sources: 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 Sales, Inc. 41 Biotronik Cardiac Pacemakers 3

Biotronik Nro, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biotronik”