510(k) Report

FDA applicant

Cardinal Health-Medical Products and Services

Waukegan, IL6 decisions1999–20138 recalls

FDA records 6 decisions for Cardinal Health-Medical Products and Services (Waukegan, IL) from 1999 to 2013: 6 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and KGO (Surgeon'S Gloves). Its devices cite 9 predicates, 2 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Cardinal Health,Medical Products and Services”.

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 Cardinal Health-Medical Products and Services’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2011: 12012: 22013: 2
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

8in 2018

2018: 8
2007high 8 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardinal Health-Medical Products and Services by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Cardinal”

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