510(k) Report

FDA applicant

Cordis Webster, Inc.

Baldwin Park, CA10 decisions1995–19994 recalls

FDA records 10 decisions for Cordis Webster, Inc. (Baldwin Park, CA) from 1995 to 1999: 10 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and DYB (Introducer, Catheter). Its devices cite 1 predicate, 1 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cordis Webster, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cordis Webster, Inc. since 2007.

Recalls per year

4in 2011

2011: 4
2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cordis Webster, Inc.’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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Other applicant names beginning “Cordis”

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