Vortex Surgical, Inc.

Contract manufacturer · Saint Charles, MO

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration

3013002167 (openFDA record; or search FDA's registration database)

FEI number

3013002167

Registered for

FDA registration year 2026

Establishment types

Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler

Owner or operator

Vortex Surgical, Inc. (FDA owner/operator no. 10052162)

Registered address

4 Research Park Dr, Suite 124, Saint Charles, MO 63304

Contract listings

2 device listings, 2 product codes, first listed Nov 28, 2016

Certification

Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.