FDA applicant

Promedical, Ltd.

Wyckoff, NJ5 decisions1994–19950 recalls

FDA records 5 decisions for Promedical, Ltd. (Wyckoff, NJ) from 1994 to 1995: 5 510(k) clearances. Most are in product codes FCG (Biopsy Needle) and LWE (Bone Marrow Collection/Transfusion Kit). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Promedical, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Promedical”

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

Promedical Products Co., Ltd. 6 Promedical Industries, Inc. 2

Promedical, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Promedical”