510(k) Report

FDA applicant

Gambro-Hospal, Inc.

Williamsburg, VA3 decisions1990–19910 recalls

FDA records 3 decisions for Gambro-Hospal, Inc. (Williamsburg, VA) from 1990 to 1991: 3 510(k) clearances. Most are in product codes FJG (Dialyzer, Parallel Flow) and KGX (Tape And Bandage, Adhesive). 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 Gambro-Hospal, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gambro-Hospal, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gambro-Hospal, 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 “Gambro-Hospal”

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