FDA applicant

Elmed USA

Appollo Beach, FL1 decision2010–20100 recalls

FDA records 1 decision for Elmed USA (Appollo Beach, FL) in 2010: 1 510(k) clearance. All are in product code FFK (Lithotriptor, Electro-Hydraulic). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Elmed USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Elmed USA by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elmed USA’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 “Elmed”

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

Elmed, Inc. 27 Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim… 1

Elmed USA

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Elmed”