FDA applicant

Strato/Infusaid, Inc.

Norwood, MA11 decisions1995–19961 recall

FDA records 11 decisions for Strato/Infusaid, Inc. (Norwood, MA) from 1995 to 1996: 11 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and LJS (Catheter, Intravascular, Therapeutic…). 1 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, general hospital panel, where it files most

How often FDA has decided Strato/Infusaid, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Strato/Infusaid, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Strato/Infusaid, Inc.’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 “Strato/Infusaid”

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

Strato Medical Corp. 46 Strato-Ray Co. 2

Strato/Infusaid, 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 “Strato/Infusaid”