FDA applicant

Synaptic Medical Corporation

Carlsbad, CA7 decisions2014–20240 recalls

FDA records 7 decisions for Synaptic Medical Corporation (Carlsbad, CA) from 2014 to 2024: 7 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and DRC (Trocar). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Synaptic Medical Limited”.

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 Synaptic Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

3in 2024

2014high 3 (2024) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Synaptic Medical Corporation by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Synaptic Medical Corporation’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 “Synaptic”

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

The Synaptic Corp. 1

Synaptic Medical Corporation

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Synaptic”