MedtechSourcebook

OSSUR

Contract manufacturer ยท Newburgh, NY

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

FDA registration
3008395545 (openFDA record; or search FDA's registration database)
FEI number
3008395545
Registered for
FDA registration year 2027
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
OSSUR Americas (FDA owner/operator no. 9026971)
Registered address
606 Broadway, Newburgh, NY 12550
Contract listings
1 device listings, 1 product codes, first listed Jan 7, 2004
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
IRAHand, External Limb Component, MechanicalClass IPhysical medicineContract manufacturingJan 7, 2004

Other contract facilities of OSSUR Americas