FDA applicant

Shape Products Co.

Oakland, CA1 decision1986–19860 recalls

FDA records 1 decision for Shape Products Co. (Oakland, CA) in 1986: 1 510(k) clearance. All are in product code DIE (Heavy Metals Control Materials). 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, clinical toxicology panel, where it files most

How often FDA has decided Shape Products Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shape Products Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Shape”

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

Shape Medical Systems, Inc. 2 Shape Memory Medical 2

Shape Products Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Shape”