Contract manufacturerPRO-TECH DESIGN & MFG., INC. (Santa Fe Springs, CA)CaliforniaAnesthesiologyCardiovascularGeneral hospitalGastroenterology and urologyNeurologyObstetrics and gynecologyOphthalmicOrthopedicPhysical medicineClinical chemistryGeneral and plastic surgeryMicrobiologyClass IIClass IClass IIIUnclassified
PRO-TECH DESIGN & MFG., INC.
Contract manufacturer · Santa Fe Springs, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2032521 (openFDA record; or search FDA's registration database)
- FEI number
- 3003574398
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- PRO-TECH Design & Mfg, Inc. (FDA owner/operator no. 9048910)
- Registered address
- 14561 MARQUARDT AVE., Santa Fe Springs, CA 90670
- Contract listings
- 60 device listings, 62 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 |
|---|---|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Class II | Anesthesiology | Contract manufacturing | Jan 20, 2015 |
| BTQ | Airway, Nasopharyngeal | Class I | Anesthesiology | Contract manufacturing | Sep 25, 2023 |
| DRB | Stylet, Catheter | Class II | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Class II | Cardiovascular | Contract manufacturing | Jan 20, 2015 |
| DTB | Permanent Pacemaker Electrode | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| DXY | Implantable Pacemaker Pulse-Generator | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Jan 20, 2015 |
| FPA | Set, Administration, Intravascular | Class II | General hospital | Contract manufacturing | Nov 5, 2020 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Oct 15, 2012 |
| GCQ | Endoscope, Flexible | Class II | Gastroenterology and urology | Contract manufacturing | May 4, 2020 |
| GXI | Probe, Radiofrequency Lesion | Class II | Neurology | Contract manufacturing | Oct 15, 2012 |
| GXR | Cover, Burr Hole | Class II | Neurology | Contract manufacturing | Jan 20, 2015 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Class II | Neurology | Contract manufacturing | Apr 14, 2021 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Class II | Neurology | Contract manufacturing | Apr 14, 2021 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract manufacturing | Jul 24, 2017 |
| HNN | Knife, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Apr 25, 2019 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Oct 15, 2012 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| IQG | Adaptor, Holder, Syringe | Class I | Physical medicine | Contract manufacturing | Jun 28, 2016 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class II | Clinical chemistry | Contract manufacturing | Nov 5, 2020 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Nov 29, 2018 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| KRG | Programmer, Pacemaker | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | Contract manufacturing | Oct 15, 2012 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | Class II | Orthopedic | Contract manufacturing | Jan 27, 2022 |
| 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 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| LXC | Monitor, Pressure, Intracompartmental | Unclassified | Orthopedic | Contract manufacturing | Jan 3, 2024 |
| LZC | Medical Glove, Specialty | Class I | General hospital | Contract manufacturing | Oct 22, 2012 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| NVY | Permanent Defibrillator Electrodes | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| NVZ | Pulse Generator, Permanent, Implantable | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| NWW | Hysteroscope Accessories | Class I | Obstetrics and gynecology | Contract manufacturing | Nov 2, 2017 |
| OAG | Garment, Storage, Peritoneal Dialysis Catheter | Class I | Physical medicine | Contract manufacturing | Apr 25, 2016 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| OJX | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| 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 |
| OSR | Pacemaker/Icd/Crt Non-Implanted Components | Class III | Cardiovascular | Contract manufacturing | Oct 22, 2012 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 20, 2015 |
| PMP | Dorsal Root Ganglion Stimulator For Pain Relief | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| QEZ | Aspiration Thrombectomy Catheter | Class II | Cardiovascular | Contract manufacturing | Jan 20, 2015 |
| QPY | Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation | Class III | Physical medicine | Contract manufacturing | Mar 27, 2025 |
| QRB | Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| QUQ | Knife, Intraocular Pressure Lowering | Class II | General and plastic surgery | Contract manufacturing | Jul 8, 2024 |
| SEP | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | Class II | Microbiology | Contract manufacturing | Apr 29, 2026 |