FDA applicant

Radius Intl., Inc.

Tarpon Springs, FL5 decisions1995–199829 recalls

FDA records 5 decisions for Radius Intl., Inc. (Tarpon Springs, FL) from 1995 to 1998: 5 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and IOR (Wheelchair, Mechanical). 29 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 Radius Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Radius Intl., Inc. since 2007.

Recalls per year

29in 2008

2007high 29 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Radius Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Radius Intl., Inc.’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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Other applicant names beginning “Radius”

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

Radius Medical Technologies, Inc. 9 Radius Medical, LLC 1

Radius Intl., Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Radius”