FDA applicant

Waterstone Medical, Inc.

Bethesda, MD1 decision1995–19950 recalls

FDA records 1 decision for Waterstone Medical, Inc. (Bethesda, MD) in 1995: 1 510(k) clearance. All are in product code KDG (Chisel (Osteotome)). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Waterstone Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Waterstone Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?