Contract manufacturerContract sterilizerSterigenics US LLC (Fort Worth, TX)TexasAnesthesiologyImmunologyGeneral and plastic surgeryDentalEar, nose and throatGastroenterology and urologyGeneral hospitalPathologyHematologyNeurologyObstetrics and gynecologyOphthalmicOrthopedicPhysical medicineRadiologyCardiovascularClass IClass IIUnclassifiedClass III
Sterigenics US LLC
Contract manufacturer and sterilizer ยท Fort Worth, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1649518 (openFDA record; or search FDA's registration database)
- FEI number
- 3001236277
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer; Contract sterilizer
- Owner or operator
- Sotera Health LLC (FDA owner/operator no. 10029425)
- Registered address
- 3125 Wichita Court, Fort Worth, TX 76140
- Contract listings
- 445 device listings, 216 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 |
|---|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Class I | Anesthesiology | Contract sterilization | Nov 19, 2012 |
| BYI | Percussor, Powered-Electric | Class II | Anesthesiology | Contract sterilization | Apr 26, 2023 |
| CCX | Support, Patient Position | Class I | Anesthesiology | Contract sterilization | Nov 15, 2012 |
| DEH | Lambda, Antigen, Antiserum, Control | Class II | Immunology | Contract sterilization | Mar 18, 2013 |
| DFH | Kappa, Antigen, Antiserum, Control | Class II | Immunology | Contract sterilization | Mar 18, 2013 |
| DWH | Blade, Saw, Surgical, Cardiovascular | Class I | General and plastic surgery | Contract sterilization | Jan 8, 2013 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | Contract sterilization | Mar 13, 2018 |
| DZL | Screw, Fixation, Intraosseous | Class II | Dental | Contract sterilization | Mar 13, 2018 |
| EMF | Knife, Surgical | Class I | General and plastic surgery | Contract sterilization | Jul 31, 2013 |
| EQJ | Bur, Ear, Nose And Throat | Class I | Ear, nose and throat | Contract sterilization | Apr 18, 2013 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Class II | Ear, nose and throat | Contract sterilization | Mar 9, 2018 |
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology and urology | Contract sterilization | Mar 18, 2013 |
| FAS | Electrode, Electrosurgical, Active, Urological | Class II | Gastroenterology and urology | Contract sterilization | Dec 3, 2012 |
| FDC | Resectoscope, Working Element | Class II | Gastroenterology and urology | Contract sterilization | Dec 3, 2012 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology and urology | Contract sterilization | Dec 3, 2012 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | Class II | Gastroenterology and urology | Contract sterilization | Aug 13, 2025 |
| FIB | Protector, Transducer, Dialysis | Class II | Gastroenterology and urology | Contract sterilization | Apr 29, 2013 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Class II | Gastroenterology and urology | Contract sterilization | Apr 29, 2013 |
| FJL | Resectoscope | Class II | Gastroenterology and urology | Contract sterilization | Dec 3, 2012 |
| FKK | Clamp, Line | Class I | Gastroenterology and urology | Contract sterilization | Apr 29, 2013 |
| FKR | Subsystem, Proportioning | Class II | Gastroenterology and urology | Contract sterilization | Apr 27, 2018 |
| FKX | System, Peritoneal, Automatic Delivery | Class II | Gastroenterology and urology | Contract sterilization | Apr 29, 2013 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | May 29, 2013 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract sterilization | Jun 11, 2010 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract sterilization | Mar 13, 2018 |
| FPA | Set, Administration, Intravascular | Class II | General hospital | Contract manufacturing | Sep 12, 2019 |
| FQH | Lavage, Jet | Class II | General hospital | Contract sterilization | Oct 31, 2012 |
| FQM | Bandage, Elastic | Class I | General hospital | Contract sterilization | May 13, 2009 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Mar 18, 2013 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | Class III | General and plastic surgery | Contract sterilization | Mar 22, 2013 |
| FZO | Chisel, Surgical, Manual | Class I | General and plastic surgery | Contract sterilization | Mar 20, 2024 |
| FZX | Guide, Surgical, Instrument | 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 |
| GAD | Retractor | Class I | General and plastic surgery | Contract sterilization | Nov 16, 2012 |
| GAX | Tourniquet, Nonpneumatic | Class I | General and plastic surgery | Contract sterilization | Nov 12, 2012 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract sterilization | Mar 22, 2013 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Sep 20, 2019 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class II | General hospital | Contract sterilization | Sep 20, 2019 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GEH | Unit, Cryosurgical, Accessories | Class II | General and plastic surgery | Contract sterilization | Mar 9, 2018 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Dec 3, 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 | Mar 9, 2018 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Jan 8, 2013 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | Class II | Hematology | Contract sterilization | Nov 30, 2020 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Class II | Neurology | Contract sterilization | Mar 13, 2018 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Class II | Neurology | Contract sterilization | Mar 13, 2018 |
| GXR | Cover, Burr Hole | Class II | Neurology | Contract sterilization | Mar 13, 2018 |
| HAE | Rongeur, Manual | Class II | Neurology | Contract sterilization | Aug 19, 2026 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract sterilization | Aug 12, 2025 |
| HBB | Motor, Drill, Pneumatic | Class II | Neurology | Contract sterilization | Jan 8, 2013 |
| HBC | Motor, Drill, Electric | Class II | Neurology | Contract sterilization | Jan 8, 2013 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract sterilization | Jan 8, 2013 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Sep 20, 2019 |
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Dec 3, 2012 |
| HIH | Hysteroscope (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Dec 3, 2012 |
| HMX | Cannula, Ophthalmic | Class I | Ophthalmic | Contract sterilization | Nov 1, 2012 |
| HNN | Knife, Ophthalmic | Class I | Ophthalmic | Contract sterilization | Nov 1, 2012 |
| HNO | Keratome, Ac-Powered | Class I | Ophthalmic | Contract sterilization | Aug 19, 2024 |
| HNY | Cystotome | Class I | Ophthalmic | Contract sterilization | Nov 8, 2012 |
| HOC | Clip, Iris Retractor | Class I | Ophthalmic | Contract sterilization | Nov 8, 2012 |
| HOZ | Sponge, Ophthalmic | Class II | Ophthalmic | Contract sterilization | Feb 26, 2013 |
| HQC | Unit, Phacofragmentation | Class II | Ophthalmic | Contract sterilization | Feb 6, 2013 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | Class II | Ophthalmic | Contract sterilization | Feb 6, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Dec 3, 2012 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jan 10, 2013 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract sterilization | Aug 29, 2023 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract sterilization | Feb 28, 2013 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Aug 29, 2023 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Mar 9, 2018 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract sterilization | Nov 25, 2014 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract sterilization | Oct 30, 2012 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Feb 27, 2013 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Jan 8, 2013 |
| HWJ | Awl | Class I | Orthopedic | Contract sterilization | Jun 13, 2023 |
| HXI | Passer, Wire, Orthopedic | Class I | Orthopedic | Contract sterilization | Aug 2, 2016 |
| HXL | Mallet | Class I | General and plastic surgery | Contract sterilization | Jul 13, 2026 |
| HXQ | Crimper, Pin | Class I | Orthopedic | Contract sterilization | Oct 30, 2014 |
| HXX | Screwdriver | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| ILO | Pack, Hot Or Cold, Water Circulating | Class II | Physical medicine | Contract sterilization | Mar 13, 2018 |
| IOY | Support, Arm | Class I | Physical medicine | Contract sterilization | Mar 19, 2013 |
| IPM | Cover, Limb | Class I | Physical medicine | Contract sterilization | Mar 13, 2018 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Class II | Radiology | Contract sterilization | Jan 9, 2013 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | Class II | Orthopedic | Contract sterilization | Jun 2, 2026 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | Class II | Orthopedic | Contract sterilization | Jan 11, 2013 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract sterilization | Jan 10, 2013 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Mar 7, 2018 |
| JDZ | Mixer, Cement, For Clinical Use | Class I | Orthopedic | Contract sterilization | Oct 29, 2012 |
| JEY | Plate, Bone | Class II | Dental | Contract sterilization | Mar 13, 2018 |
| JOL | Catheter And Tip, Suction | Class II | General hospital | Contract sterilization | Jun 15, 2009 |
| JOW | Sleeve, Limb, Compressible | Class II | Cardiovascular | Contract sterilization | Mar 13, 2018 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jan 9, 2013 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Class II | Orthopedic | Contract sterilization | Oct 25, 2019 |
| JZF | Tube, Ear Suction | Class I | Ear, nose and throat | Contract sterilization | Mar 18, 2013 |
| KCY | Tourniquet, Pneumatic | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract sterilization | May 13, 2009 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Class II | Gastroenterology and urology | Contract sterilization | Apr 29, 2013 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | Class II | Gastroenterology and urology | Contract sterilization | Apr 29, 2013 |
| KFK | Saw, Pneumatically Powered | Class I | General and plastic surgery | Contract sterilization | Mar 9, 2018 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Mar 13, 2018 |
| KGO | Surgeon'S Gloves | Class I | General and plastic surgery | Contract sterilization | Mar 9, 2018 |
| KGX | Tape And Bandage, Adhesive | Class I | General hospital | Contract sterilization | Nov 12, 2012 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Mar 13, 2018 |
| KIZ | Dish, Tissue Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KJA | Flask, Tissue Culture | Class I | Hematology | Contract sterilization | Aug 14, 2009 |
| KJF | System, Suspension, Cell Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KJG | Tube, Tissue Culture | Class I | Pathology | Contract sterilization | Nov 12, 2012 |
| KMF | Bandage, Liquid | Class I | General hospital | Contract sterilization | Mar 19, 2013 |
| KMW | Handpiece, Rotary Bone Cutting | Class II | Dental | Contract sterilization | Mar 13, 2018 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Dec 4, 2012 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class II | Gastroenterology and urology | Contract sterilization | Dec 3, 2012 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Class II | Gastroenterology and urology | Contract sterilization | Mar 9, 2018 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Apr 15, 2019 |
| KOC | Accessories, Blood Circuit, Hemodialysis | Class II | Gastroenterology and urology | Contract sterilization | Apr 29, 2013 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | Class I | General and plastic surgery | Contract sterilization | Mar 13, 2018 |
| KPE | Container, I.V. | Class II | General hospital | Contract sterilization | Apr 30, 2013 |
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | Class II | Gastroenterology and urology | Contract sterilization | Apr 29, 2013 |
| KQT | Evacuator, Gastro-Urology | Class II | Gastroenterology and urology | Contract sterilization | Sep 20, 2019 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Class II | Hematology | Contract sterilization | Apr 16, 2013 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Class III | Orthopedic | Contract sterilization | Jan 11, 2013 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract sterilization | Mar 7, 2018 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract sterilization | Jan 14, 2013 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract sterilization | Jul 21, 2026 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract sterilization | Jun 27, 2023 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract sterilization | Feb 27, 2013 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract sterilization | Aug 29, 2023 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract sterilization | Jan 14, 2013 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jan 11, 2013 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | Class II | Orthopedic | Contract sterilization | Mar 7, 2018 |
| KYD | Strip, Schirmer | Class I | Ophthalmic | Contract sterilization | Mar 9, 2018 |
| KYF | Implant, Eye Valve | Class II | Ophthalmic | Contract sterilization | Apr 26, 2023 |
| KYX | Dispenser, Liquid Medication | Class I | General hospital | Contract sterilization | Apr 17, 2013 |
| KZL | Device, Warming. Blood And Plasma | Class II | Hematology | Contract sterilization | Mar 13, 2018 |
| LCJ | Tissue Expander And Accessories | Unclassified | General and plastic surgery | Contract sterilization | Mar 22, 2013 |
| LGZ | Warmer, Thermal, Infusion Fluid | Class II | General hospital | Contract sterilization | Apr 27, 2018 |
| LOD | Bone Cement | Class II | Orthopedic | Contract sterilization | Jul 29, 2024 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract sterilization | Jan 11, 2013 |
| LRC | Instrument, Ent Manual Surgical | Class I | Ear, nose and throat | Contract sterilization | Nov 14, 2012 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract sterilization | Jan 14, 2013 |
| 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 | Jun 26, 2017 |
| LYS | Bone Mill | Class I | Orthopedic | Contract sterilization | Mar 9, 2018 |
| LZA | Polymer Patient Examination Glove | Class I | General hospital | Contract sterilization | Oct 28, 2019 |
| LZC | Medical Glove, Specialty | Class I | General hospital | Contract sterilization | Aug 9, 2024 |
| LZF | Pump, Infusion, Analytical Sampling | Class II | General hospital | Contract sterilization | Mar 9, 2018 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | Unclassified | Orthopedic | Contract sterilization | Mar 7, 2018 |
| LZN | Cement Obturator | Class II | General and plastic surgery | Contract sterilization | Jul 29, 2024 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract sterilization | Jan 11, 2013 |
| LZU | Plug, Punctum | Unclassified | Ophthalmic | Contract sterilization | Feb 28, 2013 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jan 9, 2013 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Sep 20, 2019 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class II | Orthopedic | Contract sterilization | Jan 11, 2013 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| MEG | Syringe, Antistick | Class II | General hospital | Contract sterilization | Oct 30, 2012 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract sterilization | Jan 11, 2013 |
| MGB | Device, Hemostasis, Vascular | Class III | Cardiovascular | Contract sterilization | Jan 30, 2014 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unclassified | General and plastic surgery | Contract sterilization | Mar 19, 2013 |
| MHC | Needle, Interosseous | Class II | General hospital | Contract sterilization | Jun 14, 2022 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract sterilization | Dec 8, 2020 |
| MLZ | Vitrectomy, Instrument Cutter | Class II | Ophthalmic | Contract sterilization | Feb 6, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract sterilization | Jul 29, 2024 |
| MQN | External Mandibular Fixator And/Or Distractor | Class II | Dental | Contract sterilization | Mar 13, 2018 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract sterilization | Aug 29, 2023 |
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Class III | Orthopedic | Contract sterilization | Jan 14, 2013 |
| MRD | Mammary Sizer | Unclassified | General and plastic surgery | Contract sterilization | Mar 9, 2018 |
| MUI | Media, Coupling, Ultrasound | Class II | Radiology | Contract sterilization | Jun 27, 2023 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract sterilization | Mar 14, 2018 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Class I | Ophthalmic | Contract sterilization | Feb 4, 2013 |
| 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 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract sterilization | Oct 31, 2012 |
| NDN | Cement, Bone, Vertebroplasty | Class II | Orthopedic | Contract sterilization | Jul 29, 2024 |
| NGT | Saline, Vascular Access Flush | Class II | General hospital | Contract sterilization | Mar 13, 2018 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract sterilization | Aug 29, 2023 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract sterilization | Jul 21, 2026 |
| NTX | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | Class I | General hospital | Contract sterilization | Mar 9, 2018 |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | Class I | Orthopedic | Contract sterilization | Dec 17, 2012 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Class I | Orthopedic | Contract sterilization | Nov 12, 2012 |
| OCX | Endoscopic Irrigation/Suction System | Class II | Gastroenterology and urology | Contract sterilization | Aug 13, 2025 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract sterilization | Aug 9, 2017 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract sterilization | Jan 10, 2013 |
| OKS | Lacrimal Stents And Intubation Sets | Unclassified | Ophthalmic | Contract sterilization | Mar 18, 2013 |
| 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 | Jun 13, 2023 |
| OOE | Ophthalmic Femtosecond Laser | Class II | Ophthalmic | Contract sterilization | Aug 19, 2024 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | Class I | General hospital | Contract sterilization | May 26, 2026 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | Jan 14, 2019 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract sterilization | Feb 21, 2024 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract sterilization | Mar 13, 2018 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Class II | Orthopedic | Contract sterilization | Mar 7, 2018 |
| PBJ | Cranial Distraction System | Class II | Neurology | Contract sterilization | Mar 13, 2018 |
| PEK | Spinous Process Plate | Class II | Orthopedic | Contract sterilization | Mar 20, 2024 |
| PGT | Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar | Class II | Obstetrics and gynecology | Contract sterilization | Nov 13, 2014 |
| PGZ | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use | Class II | General and plastic surgery | Contract sterilization | Sep 24, 2024 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract sterilization | Mar 20, 2024 |
| PHQ | Anterior Staple As Supplemental Fixation For Fusion | Class II | Orthopedic | Contract sterilization | Aug 29, 2023 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract sterilization | Feb 28, 2013 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | Contract sterilization | Mar 20, 2024 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract sterilization | Aug 29, 2023 |
| PML | Bone Cement, Posterior Screw Augmentation | Class II | Orthopedic | Contract sterilization | Jul 29, 2024 |
| PQJ | Intranasal Electrostimulation Device | Class II | Ophthalmic | Contract sterilization | Mar 9, 2018 |
| PZX | Left Atrial Appendage Clip, Implantable | Class II | General and plastic surgery | Contract sterilization | Oct 24, 2023 |
| QDO | Fentanyl And Other Opioid Protection Glove | Class I | General hospital | Contract sterilization | May 26, 2026 |
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | Class II | General and plastic surgery | Contract sterilization | Sep 14, 2023 |