MedtechSourcebook

GAUTHIER BIOMEDICAL, INC.

Contract manufacturer · Grafton, WI

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

FDA registration
2134947 (openFDA record; or search FDA's registration database)
FEI number
3010938185
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
GAUTHIER BIOMEDICAL, INC. (FDA owner/operator no. 9041205)
Registered address
2221 Washington St, Grafton, WI 53024
Contract listings
67 device listings, 51 product codes, first listed May 25, 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
ETNStimulator, NerveClass IIEar, nose and throatContract manufacturingNov 5, 2024
FZXGuide, Surgical, InstrumentClass IGeneral and plastic surgeryContract manufacturingJun 10, 2024
FZYHammer, SurgicalClass IGeneral and plastic surgeryContract manufacturingJun 10, 2024
GADRetractorClass IGeneral and plastic surgeryContract manufacturingFeb 21, 2023
GDJClamp, Surgical, General & Plastic SurgeryClass IGeneral and plastic surgeryContract manufacturingJun 7, 2024
GDZHandle, ScalpelClass IGeneral and plastic surgeryContract manufacturingNov 24, 2025
GFCDriver, Surgical, PinClass IGeneral and plastic surgeryContract manufacturingDec 3, 2013
HAOInstrument, Surgical, Non-PoweredClass INeurologyContract manufacturingJan 8, 2013
HAWNeurological Stereotaxic InstrumentClass IINeurologyContract manufacturingNov 6, 2017
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Class IINeurologyContract manufacturingDec 12, 2022
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingJun 11, 2024
HSBRod, Fixation, Intramedullary And AccessoriesClass IIOrthopedicContract manufacturingFeb 4, 2013
HTFCuretteClass IGeneral and plastic surgeryContract manufacturingFeb 21, 2023
HTJGauge, DepthClass IOrthopedicContract manufacturingOct 17, 2014
HTRRaspClass IGeneral and plastic surgeryContract manufacturingFeb 21, 2023
HTWBit, DrillClass IOrthopedicContract manufacturingJun 7, 2024
HTZInstrument, Cutting, OrthopedicClass IGeneral and plastic surgeryContract manufacturingDec 15, 2023
HWAImpactorClass IOrthopedicContract manufacturingDec 3, 2012
HWBExtractorClass IOrthopedicContract manufacturingJun 7, 2024
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingApr 14, 2023
HWJAwlClass IOrthopedicContract manufacturingJan 8, 2013
HWMOsteotomeClass IGeneral and plastic surgeryContract manufacturingDec 3, 2012
HWNInstrument, CompressionClass IOrthopedicContract manufacturingDec 16, 2020
HWRDriver, ProsthesisClass IOrthopedicContract manufacturingJan 8, 2013
HWTTemplateClass IOrthopedicContract manufacturingJan 11, 2011
HXBProbeClass IOrthopedicContract manufacturingJan 8, 2013
HXCWrenchClass IOrthopedicContract manufacturingJan 8, 2013
HXGTampClass IOrthopedicContract manufacturingFeb 21, 2023
HXLMalletClass IGeneral and plastic surgeryContract manufacturingJun 10, 2024
HXOPusher, SocketClass IOrthopedicContract manufacturingJun 10, 2024
HXWBenderClass IOrthopedicContract manufacturingJan 8, 2013
HXXScrewdriverClass IOrthopedicContract manufacturingMay 25, 2004
JDODevice, Fixation, Proximal Femoral, ImplantClass IIOrthopedicContract manufacturingJan 6, 2025
JDWPin, Fixation, ThreadedClass IIOrthopedicContract manufacturingJun 12, 2024
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingJun 11, 2024
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass IIOrthopedicContract manufacturingJun 11, 2024
KWIProsthesis, Elbow, Hemi-, Radial, PolymerClass IIOrthopedicContract manufacturingFeb 4, 2013
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingDec 12, 2022
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingFeb 4, 2013
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingMay 25, 2004
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass IIOrthopedicContract manufacturingJun 11, 2024
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingJun 12, 2024
MDMInstrument, Manual, Surgical, General UseClass IGeneral and plastic surgeryContract manufacturingJan 8, 2013
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingFeb 4, 2013
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingFeb 4, 2013
MQPSpinal Vertebral Body Replacement DeviceClass IIOrthopedicContract manufacturingJun 12, 2024
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingFeb 4, 2013
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingJun 12, 2024
OLOOrthopedic Stereotaxic InstrumentClass IINeurologyContract manufacturingNov 3, 2017
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisClass IIOrthopedicContract manufacturingJun 11, 2024
OURSacroiliac Joint FixationClass IIOrthopedicContract manufacturingJun 11, 2024