FDA applicant

Synapse Biomedical, Inc.

Oberline, OH2 decisions2023–20250 recalls

FDA records 2 decisions for Synapse Biomedical, Inc. (Oberline, OH) from 2023 to 2025: 1 510(k) clearance and 1 original PMA approval. Most are in product codes GZI (Stimulator, Neuromuscular, External Functional) and OIR (Diaphragmatic/Phrenic Nerve…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Synapse Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Synapse Biomedical, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Synapse Biomedical, 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) Report

Other applicant names beginning “Synapse”

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

Synapse Dental 3 Synapse Electroceutical Limited 1 Synapse Software Corp. 1

Synapse Biomedical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Synapse”