Contract sterilizerSTERI-TEK (Fremont, CA)CaliforniaCardiovascularEar, nose and throatGastroenterology and urologyGeneral and plastic surgeryGeneral hospitalNeurologyOphthalmicOrthopedicPhysical medicinePathologyClinical chemistryClass IIClass IUnclassifiedClass III
STERI-TEK
Contract sterilizer · Fremont, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3012448339 (openFDA record; or search FDA's registration database)
- FEI number
- 3012448339
- Registered for
- FDA registration year 2026
- Establishment types
- Contract sterilizer
- Owner or operator
- Steri-Tek (FDA owner/operator no. 10051493)
- Registered address
- 48225 Lakeview Blvd, Fremont, CA 94538
- Contract listings
- 44 device listings, 38 product codes, first listed Mar 25, 2016
- 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 |
|---|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract sterilization | Sep 25, 2019 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract sterilization | Apr 22, 2024 |
| ENW | Catheter, Nasopharyngeal | Class I | Ear, nose and throat | Contract sterilization | Mar 25, 2016 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, nose and throat | Contract sterilization | Feb 23, 2018 |
| FCL | Forceps, Biopsy, Non-Electric | Class I | Gastroenterology and urology | Contract sterilization | Jul 31, 2024 |
| FGY | Cannula, Injection | Class I | General and plastic surgery | Contract sterilization | Aug 12, 2016 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | Jul 14, 2021 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class II | General and plastic surgery | Contract sterilization | Jul 13, 2021 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Jan 24, 2023 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract sterilization | Aug 6, 2020 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract sterilization | Jan 10, 2024 |
| GDT | Staple, Removable (Skin) | Class I | General and plastic surgery | Contract sterilization | Apr 7, 2021 |
| GXQ | Dura Substitute | Class II | Neurology | Contract sterilization | Nov 12, 2018 |
| HNN | Knife, Ophthalmic | Class I | Ophthalmic | Contract sterilization | Jan 24, 2025 |
| HNQ | Hook, Ophthalmic | Class I | Ophthalmic | Contract sterilization | Feb 23, 2018 |
| HWQ | Passer | Class I | Orthopedic | Contract sterilization | Oct 23, 2017 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Jan 11, 2021 |
| KGX | Tape And Bandage, Adhesive | Class I | General hospital | Contract sterilization | Oct 7, 2020 |
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract sterilization | Feb 23, 2018 |
| KRD | Device, Vascular, For Promoting Embolization | Class II | Cardiovascular | Contract sterilization | Jul 26, 2018 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Class II | Cardiovascular | Contract sterilization | Feb 27, 2024 |
| LYA | Splint, Intranasal Septal | Class I | Ear, nose and throat | Contract sterilization | Mar 22, 2018 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | Class II | Orthopedic | Contract sterilization | Jan 14, 2020 |
| MGB | Device, Hemostasis, Vascular | Class III | Cardiovascular | Contract sterilization | Feb 27, 2020 |
| MLY | Vapocoolant Device | Unclassified | Physical medicine | Contract sterilization | Apr 5, 2021 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Jan 14, 2020 |
| MQX | Needle, Acupuncture, Single Use | Class II | General hospital | Contract sterilization | May 3, 2024 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | Class II | Ear, nose and throat | Contract sterilization | Aug 11, 2016 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Class I | Pathology | Contract sterilization | Jul 13, 2021 |
| OWO | Drug-Eluting Sinus Stent | Class III | Ear, nose and throat | Contract sterilization | Jul 18, 2022 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | Class II | General and plastic surgery | Contract sterilization | Jan 24, 2023 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | Class II | General and plastic surgery | Contract sterilization | Sep 17, 2021 |
| PTL | Wire, Guide, Catheter, Exempt | Class II | Cardiovascular | Contract sterilization | Oct 5, 2020 |
| PUM | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures | Class II | Cardiovascular | Contract sterilization | Apr 4, 2020 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | Class II | Clinical chemistry | Contract sterilization | Mar 25, 2022 |
| QDK | Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | Class II | Clinical chemistry | Contract sterilization | Mar 25, 2022 |
| QSZ | Absorbable Synthetic Wound Dressing | Unclassified | General and plastic surgery | Contract sterilization | Nov 12, 2018 |
| SAH | Magnetic Compression Anastomosis System | Class II | General and plastic surgery | Contract sterilization | Jun 19, 2026 |