FDA applicant

Core Healthcare, Ltd.

Battle Creek, MI1 decision1997–19970 recalls

FDA records 1 decision for Core Healthcare, Ltd. (Battle Creek, MI) in 1997: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). 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 Core Healthcare, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Core Healthcare, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Core Healthcare, Ltd.’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 “Core”

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

Core-Vent Corp. 25 Core Dynamics, Inc. 23 Core Essence Orthopaedics, LLC 6 Core-M, Inc. 4 Core Medical, Inc. 3 Core-Nexus 2 Core-Vent Bio-Engineering, Inc. 1 Core 3D Protech, S.L. 1 Core Access Surgical Technologies, Inc. 1 Core Scientific, Ltd. 1 Core Scientific Creation, Ltd. 1

Core Healthcare, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Core”