Contract manufacturerGUARDIAN MEDICAL USA, INC (Swanton, OH)OhioOrthopedicNeurologyClass II
GUARDIAN MEDICAL USA, INC
Contract manufacturer · Swanton, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3016261131 (openFDA record; or search FDA's registration database)
- FEI number
- 3016261131
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Guardian Medical USA, LLC (FDA owner/operator no. 10062293)
- Registered address
- 11360 S Airfield Rd, Swanton, OH 43558
- Contract listings
- 12 device listings, 13 product codes, first listed Jan 9, 2020
- 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 |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 30, 2020 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Dec 30, 2020 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Jun 27, 2024 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 30, 2020 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Dec 30, 2020 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jun 2, 2026 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jun 24, 2026 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jan 9, 2020 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jan 9, 2020 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Jan 9, 2020 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Jun 2, 2026 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Oct 4, 2024 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Oct 4, 2024 |