MedtechSourcebook

SYNERGETICS, INC.

Contract manufacturer · O Fallon, MO

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

FDA registration
1932402 (openFDA record; or search FDA's registration database)
FEI number
1000119053
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer
Owner or operator
SYNERGETICS, INC. (FDA owner/operator no. 9005675)
Registered address
3845 Corporate Centre Dr, O Fallon, MO 63368
Contract listings
2 device listings, 2 product codes, first listed Oct 28, 1996
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
GZXInstrument, MicrosurgicalClass INeurologyContract manufacturingOct 28, 1996
HQCUnit, PhacofragmentationClass IIOphthalmicContract manufacturingJun 16, 2025