Contract manufacturerKEYSTONE MANUFACTURING (Kalamazoo, MI)MichiganCardiovascularGeneral and plastic surgeryOrthopedicPhysical medicineRadiologyGeneral hospitalClass IIClass IUnclassified
KEYSTONE MANUFACTURING
Contract manufacturer ยท Kalamazoo, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3008236846 (openFDA record; or search FDA's registration database)
- FEI number
- 3008236846
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Keystone Manufacturing, LLC (FDA owner/operator no. 10031160)
- Registered address
- 6387 Technology Ave Ste B, Kalamazoo, MI 49009
- Contract listings
- 19 device listings, 15 product codes, first listed Jul 20, 2012
- 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 |
|---|---|---|---|---|---|
| DSS | Clip, Vascular | Class II | Cardiovascular | Contract manufacturing | Nov 14, 2022 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract manufacturing | Jul 20, 2012 |
| FZP | Clip, Implantable | Class II | General and plastic surgery | Contract manufacturing | Nov 14, 2022 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | May 4, 2023 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 16, 2022 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Jul 25, 2024 |
| ILO | Pack, Hot Or Cold, Water Circulating | Class II | Physical medicine | Contract manufacturing | Nov 16, 2022 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Class II | Radiology | Contract manufacturing | Nov 16, 2022 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Feb 4, 2025 |
| KXK | Source, Brachytherapy, Radionuclide | Class II | Radiology | Contract manufacturing | Dec 5, 2014 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class II | General hospital | Contract manufacturing | Jul 15, 2026 |
| LXC | Monitor, Pressure, Intracompartmental | Unclassified | Orthopedic | Contract manufacturing | Oct 31, 2019 |
| NEU | Marker, Radiographic, Implantable | Class II | General and plastic surgery | Contract manufacturing | Nov 16, 2022 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | Class II | General and plastic surgery | Contract manufacturing | Dec 15, 2023 |
| PND | Midline Catheter | Class II | General hospital | Contract manufacturing | Jul 15, 2026 |