510(k) Report

FDA applicant

Pudenz-Schulte Medical Research Corp.

Goleta, CA40 decisions1980–199637 recalls

FDA records 40 decisions for Pudenz-Schulte Medical Research Corp. (Goleta, CA) from 1980 to 1996: 40 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and GCY (Apparatus, Suction, Single Patient Use…). 37 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, neurology panel, where it files most

How often FDA has decided Pudenz-Schulte Medical Research Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pudenz-Schulte Medical Research Corp. since 2007.

Recalls per year

1in 2026

2009: 292013: 22020: 32021: 22026 (partial year): 1
2007high 29 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pudenz-Schulte Medical Research Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pudenz-Schulte Medical Research Corp.’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