510(k) Report

FDA applicant

Faulding Medical Device Co.

Scottsdale, AZ6 decisions1996–19970 recalls

FDA records 6 decisions for Faulding Medical Device Co. (Scottsdale, AZ) from 1996 to 1997: 6 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and MRZ (Accessories, Pump, Infusion). 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, general hospital panel, where it files most

How often FDA has decided Faulding Medical Device Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Faulding Medical Device Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Faulding”

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