FDA applicant

Edgewater Medical Equipment Systems

Mayfield Hts., OH3 decisions1986–19870 recalls

FDA records 3 decisions for Edgewater Medical Equipment Systems (Mayfield Hts., OH) from 1986 to 1987: 3 510(k) clearances. Most are in product codes FWZ (Operating Room Accessories Table Tray) and BWN (Table And Attachments, Operating-Room). 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 Edgewater Medical Equipment Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Edgewater Medical Equipment Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Edgewater Medical Equipment Systems’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 “Edgewater”

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

Edgewater Medical Systems, Inc. 2 Edgewater Medical Center 1

Edgewater Medical Equipment Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Edgewater”