Contract manufacturerGAUTHIER BIOMEDICAL, INC. (Grafton, WI)WisconsinEar, nose and throatGeneral and plastic surgeryNeurologyOrthopedicClass IIClass I
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 code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract manufacturing | Nov 5, 2024 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jun 10, 2024 |
| FZY | Hammer, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jun 10, 2024 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Feb 21, 2023 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jun 7, 2024 |
| GDZ | Handle, Scalpel | Class I | General and plastic surgery | Contract manufacturing | Nov 24, 2025 |
| GFC | Driver, Surgical, Pin | Class I | General and plastic surgery | Contract manufacturing | Dec 3, 2013 |
| HAO | Instrument, Surgical, Non-Powered | Class I | Neurology | Contract manufacturing | Jan 8, 2013 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Nov 6, 2017 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract manufacturing | Dec 12, 2022 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jun 11, 2024 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| HTF | Curette | Class I | General and plastic surgery | Contract manufacturing | Feb 21, 2023 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Oct 17, 2014 |
| HTR | Rasp | Class I | General and plastic surgery | Contract manufacturing | Feb 21, 2023 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Jun 7, 2024 |
| HTZ | Instrument, Cutting, Orthopedic | Class I | General and plastic surgery | Contract manufacturing | Dec 15, 2023 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Dec 3, 2012 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Jun 7, 2024 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Apr 14, 2023 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Jan 8, 2013 |
| HWM | Osteotome | Class I | General and plastic surgery | Contract manufacturing | Dec 3, 2012 |
| HWN | Instrument, Compression | Class I | Orthopedic | Contract manufacturing | Dec 16, 2020 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract manufacturing | Jan 8, 2013 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Jan 11, 2011 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | Jan 8, 2013 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Jan 8, 2013 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Feb 21, 2023 |
| HXL | Mallet | Class I | General and plastic surgery | Contract manufacturing | Jun 10, 2024 |
| HXO | Pusher, Socket | Class I | Orthopedic | Contract manufacturing | Jun 10, 2024 |
| HXW | Bender | Class I | Orthopedic | Contract manufacturing | Jan 8, 2013 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | May 25, 2004 |
| JDO | Device, Fixation, Proximal Femoral, Implant | Class II | Orthopedic | Contract manufacturing | Jan 6, 2025 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Jun 12, 2024 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jun 11, 2024 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Jun 11, 2024 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Dec 12, 2022 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | May 25, 2004 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class II | Orthopedic | Contract manufacturing | Jun 11, 2024 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jun 12, 2024 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Jan 8, 2013 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Jun 12, 2024 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Jun 12, 2024 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Nov 3, 2017 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Jun 11, 2024 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Jun 11, 2024 |