510(k) Report

FDA applicant

Craig & Craig, Inc.

Walker, MI1 decision1981–19813 recalls

FDA records 1 decision for Craig & Craig, Inc. (Walker, MI) in 1981: 1 510(k) clearance. All are in product code LDF (Electrode, Pacemaker, Temporary). 3 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 Craig & Craig, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Craig & Craig, Inc. since 2007.

Recalls per year

2in 2024

2019: 12024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Craig & Craig, Inc.’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

Which product codes does it file in?

  • LDFElectrode, Pacemaker, Temporary1decision

What has FDA decided for it lately?

  • K803086Myowire-Atemporary Cardiac Pacing WireCraig & Craig, Inc. · 19813 recalls

The one decision as Craig & Craig, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K803086Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number…Apr 8, 2024Class II
  • K803086Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223Apr 8, 2024Class II
  • K803086A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode…Jun 21, 2019Class II