FDA applicant

Gambro-Hosp-Cobe, Inc.

Lakewood, CO1 decision1991–19910 recalls

FDA records 1 decision for Gambro-Hosp-Cobe, Inc. (Lakewood, CO) in 1991: 1 510(k) clearance. All are in product code FKP (System, Dialysate Delivery, Single Patient). 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-Hosp-Cobe, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gambro-Hosp-Cobe, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gambro-Hosp-Cobe, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gambro-Hosp-Cobe, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Gambro-Hosp-Cobe”

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

Gambro, Inc. 87 Gambro Renal Products 37 Gambro Healthcare 13 Gambro-Hospal, Inc. 3 Gambro Bct, Inc. 2 Gambro Renal Care Products 2 Gambro Services, Inc. 1

Gambro-Hosp-Cobe, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Gambro-Hosp-Cobe”