Contract sterilizerSterigenics US LLC (Gurnee, IL)IllinoisAnesthesiologyGeneral hospitalImmunologyCardiovascularDentalGeneral and plastic surgeryEar, nose and throatGastroenterology and urologyPathologyHematologyNeurologyObstetrics and gynecologyOphthalmicOrthopedicPhysical medicineClinical chemistryMicrobiologyClass IClass IIUnclassifiedClass III
Sterigenics US LLC
Contract sterilizer · Gurnee, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1423662 (openFDA record; or search FDA's registration database)
- FEI number
- 3000215273
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract sterilizer
- Owner or operator
- Sotera Health LLC (FDA owner/operator no. 10029425)
- Registered address
- 1003 Lakeside Drive, Gurnee, IL 60031
- Contract listings
- 416 device listings, 217 product codes, first listed May 13, 2009
- 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 |
|---|---|---|---|---|---|
| BSR | Stylet, Tracheal Tube | Class I | Anesthesiology | Contract sterilization | Jul 1, 2013 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Class II | Anesthesiology | Contract sterilization | Jun 6, 2013 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | Class I | Anesthesiology | Contract sterilization | Nov 15, 2012 |
| BYY | Tube, Aspirating, Flexible, Connecting | Class II | General hospital | Contract sterilization | Nov 1, 2012 |
| BYZ | Trap, Sterile Specimen | Class II | General hospital | Contract sterilization | May 19, 2016 |
| BZA | Connector, Airway (Extension) | Class I | Anesthesiology | Contract sterilization | Apr 30, 2013 |
| CAF | Nebulizer (Direct Patient Interface) | Class II | Anesthesiology | Contract sterilization | Jun 6, 2013 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Class II | Anesthesiology | Contract sterilization | Jun 6, 2013 |
| CCX | Support, Patient Position | Class I | Anesthesiology | Contract sterilization | Nov 15, 2012 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | Class II | Immunology | Contract sterilization | Aug 9, 2017 |
| DRX | Electrode, Electrocardiograph | Class II | Cardiovascular | Contract sterilization | Nov 1, 2012 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract sterilization | May 31, 2013 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract sterilization | Nov 1, 2012 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | Contract sterilization | Oct 31, 2012 |
| DZM | Needle, Dental | Class I | Dental | Contract sterilization | Dec 4, 2012 |
| EFQ | Gauze/Sponge, Internal | Unclassified | General and plastic surgery | Contract sterilization | May 1, 2013 |
| EHD | Unit, X-Ray, Extraoral With Timer | Class II | Dental | Contract sterilization | Jul 17, 2013 |
| EMX | Balloon, Epistaxis | Class I | Ear, nose and throat | Contract sterilization | Mar 15, 2018 |
| EYI | Adaptor, Ureteral Catheter | Class I | Gastroenterology and urology | Contract sterilization | Dec 28, 2012 |
| EYJ | Holder, Ureteral Catheter | Class I | Gastroenterology and urology | Contract sterilization | Dec 5, 2019 |
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology and urology | Contract sterilization | Mar 18, 2013 |
| EZX | Mesh, Surgical, Metal | Class II | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| EZY | Device, Incontinence, Mechanical/Hydraulic | Class III | Gastroenterology and urology | Contract sterilization | Mar 19, 2018 |
| FAF | Prosthesis, Testicular | Class III | Gastroenterology and urology | Contract sterilization | Nov 13, 2012 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | Class II | Gastroenterology and urology | Contract sterilization | Dec 5, 2019 |
| FDG | Retractor, Fiberoptic | Class I | Gastroenterology and urology | Contract sterilization | Oct 31, 2012 |
| FFK | Lithotriptor, Electro-Hydraulic | Class II | Gastroenterology and urology | Contract sterilization | Nov 1, 2012 |
| FGY | Cannula, Injection | Class I | General and plastic surgery | Contract sterilization | Nov 12, 2012 |
| FHW | Device, Impotence, Mechanical/Hydraulic | Class III | Gastroenterology and urology | Contract sterilization | Nov 13, 2012 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | Oct 24, 2012 |
| FMG | Stopcock, I.V. Set | Class II | General hospital | Contract sterilization | Oct 30, 2012 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract sterilization | Jun 11, 2010 |
| FOX | Stand, Infusion | Class I | General hospital | Contract sterilization | Jul 25, 2013 |
| FPA | Set, Administration, Intravascular | Class II | General hospital | Contract sterilization | Oct 30, 2012 |
| FPX | Strip, Adhesive, Closure, Skin | Class I | General hospital | Contract sterilization | Jan 22, 2014 |
| FPY | Sheet, Burn | Class I | General hospital | Contract sterilization | Oct 29, 2012 |
| FQH | Lavage, Jet | Class II | General hospital | Contract sterilization | Oct 31, 2012 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Mar 18, 2013 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract sterilization | Nov 12, 2012 |
| FZQ | Clip, Removable (Skin) | Class I | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| FZZ | Marker, Skin | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GAB | Needle, Suturing, Disposable | Class I | General and plastic surgery | Contract sterilization | Oct 30, 2012 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | Class II | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GAN | Suture, Absorbable, Synthetic | Class II | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract sterilization | Nov 1, 2012 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| GCE | Adaptor, Catheter | Class I | General and plastic surgery | Contract sterilization | Jul 26, 2013 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Nov 1, 2012 |
| GDI | Dissector, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 14, 2012 |
| GDO | Applier, Surgical, Clip | Class I | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GDT | Staple, Removable (Skin) | Class I | General and plastic surgery | Contract sterilization | Jul 31, 2013 |
| GDW | Staple, Implantable | Class II | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GDX | Scalpel, One-Piece | Class I | General and plastic surgery | Contract sterilization | Nov 30, 2012 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GES | Blade, Scalpel | Class I | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | Class I | General and plastic surgery | Contract sterilization | Feb 27, 2018 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | Class II | Hematology | Contract sterilization | Nov 30, 2020 |
| GXY | Electrode, Cutaneous | Class II | Neurology | Contract sterilization | Mar 15, 2018 |
| HDA | Forceps, Obstetrical | Class II | Obstetrics and gynecology | Contract sterilization | Feb 27, 2018 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Feb 27, 2018 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | Class II | Obstetrics and gynecology | Contract sterilization | May 29, 2013 |
| HGX | Pump, Breast, Powered | Class II | Obstetrics and gynecology | Contract sterilization | Jan 27, 2021 |
| HIF | Insufflator, Laparoscopic | Class II | Obstetrics and gynecology | Contract sterilization | Oct 31, 2012 |
| HIG | Insufflator, Hysteroscopic | Class II | Obstetrics and gynecology | Contract sterilization | Nov 1, 2012 |
| HJM | Transilluminator, Ac-Powered | Class II | Ophthalmic | Contract sterilization | Oct 31, 2012 |
| HNA | Spud, Ophthalmic | Class I | Ophthalmic | Contract sterilization | May 2, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Mar 16, 2018 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Nov 1, 2012 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Aug 27, 2025 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract sterilization | Apr 12, 2013 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract sterilization | Feb 24, 2020 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Mar 31, 2013 |
| HTD | Forceps | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| HTO | Reamer | Class I | Orthopedic | Contract sterilization | Dec 4, 2012 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract sterilization | Aug 9, 2017 |
| HWA | Impactor | Class I | Orthopedic | Contract sterilization | Nov 12, 2012 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Oct 31, 2012 |
| HWD | Starter, Bone Screw | Class I | Orthopedic | Contract sterilization | Oct 21, 2020 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | May 3, 2013 |
| HWK | Trephine | Class I | Orthopedic | Contract sterilization | Feb 21, 2024 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract sterilization | Feb 21, 2024 |
| HWT | Template | Class I | Orthopedic | Contract sterilization | Jul 17, 2013 |
| HXG | Tamp | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| HXI | Passer, Wire, Orthopedic | Class I | Orthopedic | Contract sterilization | Aug 2, 2016 |
| HXX | Screwdriver | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| IQG | Adaptor, Holder, Syringe | Class I | Physical medicine | Contract sterilization | Jun 1, 2026 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Class II | Orthopedic | Contract sterilization | Oct 21, 2020 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract sterilization | Apr 8, 2013 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract sterilization | Mar 20, 2013 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| JDZ | Mixer, Cement, For Clinical Use | Class I | Orthopedic | Contract sterilization | Oct 29, 2012 |
| JEC | Component, Traction, Invasive | Class II | Orthopedic | Contract sterilization | Feb 24, 2020 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class I | Clinical chemistry | Contract sterilization | Nov 13, 2012 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jun 21, 2018 |
| JZQ | Plates And Equipment, Radial Immunodiffusion | Class I | Immunology | Contract sterilization | Nov 1, 2012 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General hospital | Contract sterilization | Feb 25, 2025 |
| KDC | Instrument, Surgical, Disposable | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| KDQ | Bottle, Collection, Vacuum | Class II | General hospital | Contract sterilization | Oct 31, 2012 |
| KES | Coverslips, Microscope Slide | Class I | Pathology | Contract sterilization | Nov 1, 2012 |
| KGX | Tape And Bandage, Adhesive | Class I | General hospital | Contract sterilization | Nov 12, 2012 |
| KIH | Dispenser, Cement | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Feb 21, 2024 |
| KIY | Chamber, Slide Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KIZ | Dish, Tissue Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KJA | Flask, Tissue Culture | Class I | Hematology | Contract sterilization | Aug 14, 2009 |
| KJC | Bottle, Roller, Tissue Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KJF | System, Suspension, Cell Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KMJ | Lubricant, Patient | Class I | General hospital | Contract sterilization | Mar 18, 2013 |
| KMK | Device, Intravascular Catheter Securement | Class I | General hospital | Contract sterilization | May 7, 2013 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Class II | Gastroenterology and urology | Contract sterilization | Nov 1, 2012 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Mar 16, 2018 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Class I | Gastroenterology and urology | Contract sterilization | May 13, 2009 |
| KPE | Container, I.V. | Class II | General hospital | Contract sterilization | Oct 31, 2012 |
| KQT | Evacuator, Gastro-Urology | Class II | Gastroenterology and urology | Contract sterilization | Nov 1, 2012 |
| KRD | Device, Vascular, For Promoting Embolization | Class II | Cardiovascular | Contract sterilization | Mar 16, 2018 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Apr 10, 2013 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Class II | Hematology | Contract sterilization | Nov 13, 2012 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract sterilization | Feb 26, 2019 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract sterilization | Feb 24, 2020 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract sterilization | Mar 21, 2018 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract sterilization | Apr 12, 2013 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract sterilization | Feb 24, 2020 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Feb 27, 2026 |
| KYW | Container, Liquid Medication, Graduated | Class I | General hospital | Contract sterilization | Nov 15, 2012 |
| KYZ | Syringe, Irrigating (Non Dental) | Class I | General hospital | Contract sterilization | Nov 15, 2012 |
| LHI | Set, I.V. Fluid Transfer | Class II | General hospital | Contract sterilization | Aug 10, 2016 |
| LJH | System, Irrigation, Urological | Class II | Gastroenterology and urology | Contract sterilization | Nov 1, 2012 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class II | Microbiology | Contract sterilization | Apr 3, 2018 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract sterilization | Apr 11, 2013 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Class III | Cardiovascular | Contract sterilization | Oct 22, 2024 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class I | Clinical chemistry | Contract sterilization | Nov 1, 2012 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| LYA | Splint, Intranasal Septal | Class I | Ear, nose and throat | Contract sterilization | Oct 31, 2012 |
| LYC | Bone Grafting Material, Synthetic | Class II | Dental | Contract sterilization | Oct 31, 2012 |
| LYV | Label Or Tag, Sterile | Class I | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| LZN | Cement Obturator | Class II | General and plastic surgery | Contract sterilization | Apr 8, 2013 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract sterilization | Apr 10, 2013 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Apr 25, 2013 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jun 21, 2018 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Oct 31, 2012 |
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Aug 27, 2025 |
| MDB | System, Blood Culturing | Class I | Microbiology | Contract sterilization | May 1, 2013 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| MGB | Device, Hemostasis, Vascular | Class III | Cardiovascular | Contract sterilization | Oct 31, 2012 |
| MJG | Device, Percutaneous, Biopsy | Class I | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract sterilization | Dec 8, 2020 |
| MKJ | Automated External Defibrillators (Non-Wearable) | Class III | Cardiovascular | Contract sterilization | Mar 15, 2018 |
| MKY | System, Skin Closure | Class I | General and plastic surgery | Contract sterilization | Dec 6, 2019 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract sterilization | Mar 21, 2018 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract sterilization | Mar 21, 2018 |
| MON | System, Hemodialysis, Remote Accessories | Class I | Gastroenterology and urology | Contract sterilization | Mar 16, 2018 |
| MQK | Labware, Assisted Reproduction | Class II | Obstetrics and gynecology | Contract sterilization | Nov 1, 2012 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract sterilization | Jun 21, 2017 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Mar 16, 2018 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract sterilization | Nov 1, 2012 |
| MTJ | Wax, Bone | Unclassified | Orthopedic | Contract sterilization | Mar 15, 2018 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract sterilization | Feb 20, 2020 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| NAC | Dressing, Wound, Hydrophilic | Class I | General and plastic surgery | Contract sterilization | Feb 4, 2013 |
| NAD | Dressing, Wound, Occlusive | Class I | General and plastic surgery | Contract sterilization | Dec 19, 2012 |
| NDL | Pin, Fixation, Smooth, Metallic | Class II | Orthopedic | Contract sterilization | Feb 25, 2025 |
| NDN | Cement, Bone, Vertebroplasty | Class II | Orthopedic | Contract sterilization | Mar 15, 2018 |
| NDP | Accessories, Implant, Dental, Endosseous | Class I | Dental | Contract sterilization | Nov 9, 2012 |
| NEC | Bandage, Liquid, Skin Protectant | Class I | General hospital | Contract sterilization | Nov 25, 2014 |
| NEP | System/Device, Pharmacy Compounding | Class II | General hospital | Contract sterilization | Jul 31, 2013 |
| NGT | Saline, Vascular Access Flush | Class II | General hospital | Contract sterilization | Mar 13, 2018 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | Contract sterilization | Apr 22, 2013 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | Class II | Ear, nose and throat | Contract sterilization | Oct 31, 2012 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract sterilization | Mar 21, 2018 |
| NPZ | Bone Grafting Material, Dental, With Biologic Component | Class III | Dental | Contract sterilization | Oct 31, 2012 |
| NQO | Prosthesis, Spinous Process Spacer/Plate | Class III | Orthopedic | Contract sterilization | Nov 1, 2012 |
| NRB | Wound Cleaner, Ultrasound | Class II | General and plastic surgery | Contract sterilization | Jun 21, 2017 |
| NVY | Permanent Defibrillator Electrodes | Class III | Cardiovascular | Contract sterilization | Oct 22, 2024 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | Class II | General and plastic surgery | Contract sterilization | Nov 13, 2012 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Class II | Gastroenterology and urology | Contract sterilization | Oct 31, 2012 |
| OCX | Endoscopic Irrigation/Suction System | Class II | Gastroenterology and urology | Contract sterilization | Nov 1, 2012 |
| ODC | Endoscope Channel Accessory | Class II | Gastroenterology and urology | Contract sterilization | Jun 18, 2019 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract sterilization | Jun 21, 2017 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract sterilization | Aug 27, 2025 |
| OLL | Septal Stapler/Absorbable Staples | Class II | General and plastic surgery | Contract sterilization | May 1, 2013 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract sterilization | Oct 31, 2012 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | Contract sterilization | Feb 27, 2026 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Class II | Orthopedic | Contract sterilization | Feb 27, 2026 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class II | Orthopedic | Contract sterilization | Feb 27, 2026 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | Mar 16, 2018 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract sterilization | Mar 21, 2018 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract sterilization | May 1, 2013 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract sterilization | Jun 21, 2017 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract sterilization | Jun 21, 2017 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| PBI | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | Class II | Orthopedic | Contract sterilization | Feb 27, 2026 |
| PEH | Hemodialysis Catheter Luer End Cap | Class II | Gastroenterology and urology | Contract sterilization | Dec 5, 2019 |
| PEK | Spinous Process Plate | Class II | Orthopedic | Contract sterilization | Mar 16, 2018 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract sterilization | Feb 28, 2018 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract sterilization | Dec 5, 2019 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| PLF | Bone Wedge | Class II | Orthopedic | Contract sterilization | Mar 16, 2018 |
| PLI | Gastrointestional Tube Holder | Class II | Gastroenterology and urology | Contract sterilization | Feb 24, 2020 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Class II | Gastroenterology and urology | Contract sterilization | Mar 14, 2018 |
| QAI | Powered Microneedle Device | Class II | General and plastic surgery | Contract sterilization | Jun 1, 2026 |
| QBP | Cap, Device Disinfectant | Class II | General hospital | Contract sterilization | Feb 20, 2020 |
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | Class II | General and plastic surgery | Contract sterilization | Jun 1, 2026 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unclassified | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| SCN | Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief | Class II | Neurology | Contract sterilization | Jun 18, 2026 |