510(k) Report

FDA applicant

Holmed Corp.

South Easton, MA2 decisions1993–19940 recalls

FDA records 2 decisions for Holmed Corp. (South Easton, MA) from 1993 to 1994: 2 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FHQ (Holder, Needle, Gastroenterologic). 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 Holmed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Holmed Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Holmed Corp.’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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