FDA applicant

Banyan Medical, LLC

Warwick, RI1 decision2014–20142 recalls

FDA records 1 decision for Banyan Medical, LLC (Warwick, RI) in 2014: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Banyan Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2016

2014high 2 (2016) · low 0 (2014)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Banyan”

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

Banyan USA, LLC 1 Banyan Biomarkers, Inc. 1

Banyan Medical, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Banyan”