FDA applicant

Accumed Systems, Inc.

Shaker Heights, OH1 decision1990–19900 recalls

FDA records 1 decision for Accumed Systems, Inc. (Shaker Heights, OH) in 1990: 1 510(k) clearance. All are in product code DXT (Injector And Syringe, Angiographic). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Accumed Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Accumed”

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

Accumed Intl., Inc. 12 Accumed Healthcare (Shanghai), Inc. 2

Accumed Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Accumed”