FDA applicant

Pinnacle Co., Ltd.

Shandong, CN3 decisions2008–20080 recalls

FDA records 3 decisions for Pinnacle Co., Ltd. (Shandong, CN) in 2008: 3 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). 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 hospital panel, where it files most

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

FDA decisions per year

3in 2008

2008high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Pinnacle Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Pinnacle”

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

Pinnacle Spine Group, LLC 13 Pinnacle Biologics, Inc. 2 Pinnacle Distributors, Inc. 2 Pinnacle Products, Inc. 1 Pinnacle Intl., Inc. 1

Pinnacle Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Pinnacle”