MedtechSourcebook

Brasseler U.S.A. Medical, LLC

Contract manufacturer · Savannah, GA

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

FDA registration
2025102 (openFDA record; or search FDA's registration database)
FEI number
3004949275
Registered for
FDA registration year 2026
Establishment types
Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
Brasseler U.S.A. Medical, LLC (FDA owner/operator no. 9010748)
Registered address
1 Brasseler Blvd, Savannah, GA 31419
Contract listings
6 device listings, 6 product codes, first listed Jun 21, 1994
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
DWHBlade, Saw, Surgical, CardiovascularClass IGeneral and plastic surgeryContract manufacturingDec 14, 2012
HABSaw, Powered, And AccessoriesClass IGeneral and plastic surgeryContract manufacturingJun 21, 1994
HTTBurr, OrthopedicClass IOrthopedicContract manufacturingJan 7, 2013
KFKSaw, Pneumatically PoweredClass IGeneral and plastic surgeryContract manufacturingOct 19, 2015
LGHInstrument, Cast Removal, Ac-PoweredClass IOrthopedicContract manufacturingAug 4, 2026
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingJan 11, 2013