FDA applicant

Hydro Floss, Inc.

Birmingham, AL1 decision1994–19940 recalls

FDA records 1 decision for Hydro Floss, Inc. (Birmingham, AL) in 1994: 1 510(k) clearance. All are in product code EFS (Unit, Oral Irrigation). 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, dental panel, where it files most

How often FDA has decided Hydro Floss, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hydro Floss, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hydro Floss, 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 “Hydro”

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

Hydro-Med Products, Inc. 13 Hydro-Pulse Research, Inc. 1

Hydro Floss, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hydro”