Contract manufacturerPRO-TECH Design & Mfg, Inc. (Arlington, TX)TexasCardiovascularGeneral hospitalNeurologyOrthopedicClinical chemistryGeneral and plastic surgeryClass IIClass IClass III
PRO-TECH Design & Mfg, Inc.
Contract manufacturer ยท Arlington, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010531069 (openFDA record; or search FDA's registration database)
- FEI number
- 3010531069
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Repackager or relabeler
- Owner or operator
- PRO-TECH Design & Mfg, Inc. (FDA owner/operator no. 9048910)
- Registered address
- 4041 Express Street, Arlington, TX 76001
- Contract listings
- 21 device listings, 27 product codes, first listed Oct 15, 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 |
|---|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Jun 18, 2025 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | Dec 8, 2022 |
| FPA | Set, Administration, Intravascular | Class II | General hospital | Contract manufacturing | Nov 5, 2020 |
| FQH | Lavage, Jet | Class II | General hospital | Contract manufacturing | Jun 18, 2025 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Class II | Neurology | Contract manufacturing | Dec 13, 2023 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class II | Clinical chemistry | Contract manufacturing | Nov 5, 2020 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract manufacturing | Jun 9, 2022 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | Contract manufacturing | Oct 15, 2012 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Class III | Neurology | Contract manufacturing | Mar 12, 2018 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Nov 30, 2021 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract manufacturing | Feb 20, 2018 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Nov 4, 2024 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| PJS | Stimulator, Electrical, Implanted, For Essential Tremor | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| PMP | Dorsal Root Ganglion Stimulator For Pain Relief | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | Class II | General and plastic surgery | Contract manufacturing | Aug 18, 2023 |
| QRB | Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |