FDA applicant

Medsynaptic Private, Ltd.

Pune, IN3 decisions2009–20190 recalls

FDA records 3 decisions for Medsynaptic Private, Ltd. (Pune, IN) from 2009 to 2019: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 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, radiology panel, where it files most

How often FDA has decided Medsynaptic Private, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Medsynaptic Private, Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medsynaptic Private, Ltd.’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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Medsynaptic Private, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?