510(k) Report

FDA applicant

Schering-Plough Healthcare Products, Inc.

Berkeley Heights, NJ2 decisions2003–20050 recalls

FDA records 2 decisions for Schering-Plough Healthcare Products, Inc. (Berkeley Heights, NJ) from 2003 to 2005: 2 510(k) clearances. All are in product code GEH (Unit, Cryosurgical, Accessories). Its devices cite 5 predicates, 1 of them its own earlier devices. 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 and plastic surgery panel, where it files most

How often FDA has decided Schering-Plough Healthcare Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Schering-Plough Healthcare Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Schering-Plough Healthcare Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Schering-Plough Healthcare Products…’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 “Schering-Plough”

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