MedtechSourcebook

STEPHENS INSTRUMENTS, INC

Contract manufacturer ยท Lexington, KY

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

FDA registration
1045379 (openFDA record; or search FDA's registration database)
FEI number
1045379
Registered for
FDA registration year 2027
Establishment types
Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler; Single-use device reprocessor
Owner or operator
STEPHENS INSTRUMENTS, INC. (FDA owner/operator no. 1045379)
Registered address
2500 Sandersville Rd, Lexington, KY 40511
Contract listings
1 device listings, 1 product codes, first listed Dec 12, 2013
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.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
HOCClip, Iris RetractorClass IOphthalmicContract manufacturingDec 12, 2013