Contract sterilizerSterigenics US LLC (Charlotte, NC)North CarolinaAnesthesiologyGeneral hospitalClinical toxicologyCardiovascularDentalGeneral and plastic surgeryEar, nose and throatGastroenterology and urologyPathologyClinical chemistryNeurologyObstetrics and gynecologyOphthalmicOrthopedicPhysical medicineRadiologyHematologyClass IClass IIUnclassifiedClass III
Sterigenics US LLC
Contract sterilizer · Charlotte, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1058584 (openFDA record; or search FDA's registration database)
- FEI number
- 1000219637
- 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
- 10811 Withers Cove Park Drive, Charlotte, NC 28278
- Contract listings
- 325 device listings, 208 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 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | Class II | Anesthesiology | Contract sterilization | Mar 21, 2017 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | Class I | Anesthesiology | Contract sterilization | Nov 15, 2012 |
| BYX | Tubing, Pressure And Accessories | Class I | Anesthesiology | Contract sterilization | Dec 14, 2012 |
| CAK | Microfilter, Blood Transfusion | Class II | General hospital | Contract sterilization | Nov 30, 2012 |
| CBH | Device, Fixation, Tracheal Tube | Class I | Anesthesiology | Contract sterilization | Apr 26, 2017 |
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | Class II | Clinical toxicology | Contract sterilization | Jun 29, 2016 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract sterilization | Jul 16, 2020 |
| DQO | Catheter, Intravascular, Diagnostic | Class II | Cardiovascular | Contract sterilization | Jun 28, 2013 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract sterilization | Dec 10, 2012 |
| DRC | Trocar | Class II | Cardiovascular | Contract sterilization | Aug 12, 2015 |
| DSK | Computer, Blood-Pressure | Class II | Cardiovascular | Contract sterilization | Jul 16, 2020 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract sterilization | Nov 19, 2012 |
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract sterilization | Jun 29, 2016 |
| DZP | Instrument, Diamond, Dental | Class I | Dental | Contract sterilization | Nov 8, 2012 |
| EFN | Cotton, Roll | Class I | Dental | Contract sterilization | Jul 26, 2013 |
| EFQ | Gauze/Sponge, Internal | Unclassified | General and plastic surgery | Contract sterilization | May 30, 2013 |
| EJL | Bur, Dental | Class I | Dental | Contract sterilization | Nov 8, 2012 |
| EJQ | Wheel, Polishing Agent | Class I | Dental | Contract sterilization | Aug 18, 2017 |
| EMF | Knife, Surgical | Class I | General and plastic surgery | Contract sterilization | Nov 22, 2022 |
| 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 | Nov 13, 2020 |
| EXE | Protector, Ostomy | Class I | Gastroenterology and urology | Contract sterilization | Dec 9, 2016 |
| EYH | Table, Cysto, Non-Electrical | Class I | Gastroenterology and urology | Contract sterilization | Jun 28, 2013 |
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology and urology | Contract sterilization | Nov 14, 2012 |
| EZP | Rod, Colostomy | Class II | Gastroenterology and urology | Contract sterilization | Apr 23, 2013 |
| FCG | Biopsy Needle | Class II | Gastroenterology and urology | Contract sterilization | Dec 14, 2012 |
| FCL | Forceps, Biopsy, Non-Electric | Class I | Gastroenterology and urology | Contract sterilization | Mar 21, 2017 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Class II | Gastroenterology and urology | Contract sterilization | Jan 24, 2019 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | Gastroenterology and urology | Contract sterilization | Dec 10, 2012 |
| FHQ | Holder, Needle, Gastroenterologic | Class I | Gastroenterology and urology | Contract sterilization | Jul 11, 2013 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | Nov 30, 2012 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract sterilization | Jun 11, 2010 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract sterilization | Aug 14, 2017 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class II | General and plastic surgery | Contract sterilization | Mar 22, 2017 |
| FMP | Protector, Skin Pressure | Class I | General hospital | Contract sterilization | Nov 12, 2012 |
| FMQ | Restraint, Protective | Class I | General hospital | Contract sterilization | Feb 24, 2020 |
| FON | Bag, Drainage, With Adhesive, Ostomy | Class I | Gastroenterology and urology | Contract sterilization | Jun 28, 2013 |
| FPY | Sheet, Burn | Class I | General hospital | Contract sterilization | Oct 29, 2012 |
| FQH | Lavage, Jet | Class II | General hospital | Contract sterilization | Oct 31, 2012 |
| FQM | Bandage, Elastic | Class I | General hospital | Contract sterilization | May 13, 2009 |
| FQZ | Thermometer, Clinical Color Change | Class I | General hospital | Contract sterilization | Mar 26, 2014 |
| FRL | Fiber, Medical, Absorbent | Class I | General hospital | Contract sterilization | Nov 15, 2012 |
| FRN | Pump, Infusion | Class II | General hospital | Contract sterilization | Oct 29, 2012 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| FSH | Tray, Surgical, Needle | Class I | General and plastic surgery | Contract sterilization | Dec 14, 2012 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| FTA | Light, Surgical, Accessories | Class II | General and plastic surgery | Contract sterilization | Apr 26, 2017 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract sterilization | Jun 20, 2017 |
| FWZ | Operating Room Accessories Table Tray | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| FXX | Mask, Surgical | Class II | General and plastic surgery | Contract sterilization | Apr 23, 2013 |
| FYA | Gown, Surgical | Class II | General and plastic surgery | Contract sterilization | Apr 23, 2013 |
| FYD | Apparatus, Exhaust, Surgical | Class II | General and plastic surgery | Contract sterilization | Jun 20, 2017 |
| FYE | Dress, Surgical | Class I | General and plastic surgery | Contract sterilization | Jun 20, 2017 |
| FZT | Cutter, Surgical | Class I | General and plastic surgery | Contract sterilization | Nov 30, 2012 |
| FZW | Expander, Surgical, Skin Graft | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| GAB | Needle, Suturing, Disposable | Class I | General and plastic surgery | Contract sterilization | Oct 30, 2012 |
| GAC | Rasp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GAG | Stapler, Surgical | Class II | General hospital | Contract sterilization | Oct 29, 2012 |
| GAL | Suture, Absorbable, Natural | Class II | General and plastic surgery | Contract sterilization | Feb 27, 2018 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | Class II | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GAO | Suture, Nonabsorbable | Class II | General and plastic surgery | Contract sterilization | Feb 27, 2018 |
| GAP | Suture, Nonabsorbable, Silk | Class II | General and plastic surgery | Contract sterilization | Feb 27, 2018 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | Class II | General and plastic surgery | Contract sterilization | Feb 27, 2018 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract sterilization | Feb 27, 2018 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Apr 19, 2013 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class I | General and plastic surgery | Contract sterilization | Oct 23, 2012 |
| GCZ | Retainer, Surgical | Class I | General and plastic surgery | Contract sterilization | Nov 30, 2012 |
| GDI | Dissector, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 1, 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 29, 2012 |
| GDX | Scalpel, One-Piece | Class I | General and plastic surgery | Contract sterilization | Nov 30, 2012 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | Class I | General and plastic surgery | Contract sterilization | Nov 15, 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 | Apr 23, 2013 |
| 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 | Apr 19, 2013 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract sterilization | Feb 27, 2018 |
| GEY | Motor, Surgical Instrument, Ac-Powered | Class I | General and plastic surgery | Contract sterilization | Nov 14, 2012 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GFD | Dermatome | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Jan 8, 2013 |
| GFG | Bit, Surgical | Class I | General and plastic surgery | Contract sterilization | Apr 18, 2013 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Class II | Clinical chemistry | Contract sterilization | Mar 21, 2013 |
| HBB | Motor, Drill, Pneumatic | Class II | Neurology | Contract sterilization | Nov 13, 2020 |
| HBC | Motor, Drill, Electric | Class II | Neurology | Contract sterilization | Nov 13, 2020 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract sterilization | Nov 14, 2012 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | Class II | Neurology | Contract sterilization | Nov 14, 2012 |
| 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 |
| HFX | Clamp, Circumcision | Class II | Obstetrics and gynecology | Contract sterilization | Feb 26, 2018 |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | Class II | Ophthalmic | Contract sterilization | Nov 25, 2014 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class I | Ophthalmic | Contract sterilization | Oct 29, 2012 |
| HPZ | Implant, Eye Sphere | Class II | Ophthalmic | Contract sterilization | Apr 29, 2021 |
| HQC | Unit, Phacofragmentation | Class II | Ophthalmic | Contract sterilization | Feb 13, 2018 |
| HQN | Conformer, Ophthalmic | Class II | Ophthalmic | Contract sterilization | Apr 29, 2021 |
| HRP | Pen, Marking, Surgical | Class I | Ophthalmic | Contract sterilization | Apr 26, 2017 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Jan 15, 2018 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Apr 17, 2013 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract sterilization | Mar 8, 2017 |
| HSP | Splint, Traction | Class I | Orthopedic | Contract sterilization | Oct 29, 2012 |
| HST | Apparatus, Traction, Non-Powered | Class I | Orthopedic | Contract sterilization | Jun 28, 2013 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Jan 25, 2018 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract sterilization | Apr 18, 2013 |
| HTO | Reamer | Class I | Orthopedic | Contract sterilization | Dec 4, 2012 |
| HTR | Rasp | Class I | General and plastic surgery | Contract sterilization | Jan 25, 2018 |
| HTS | Knife, Orthopedic | Class I | Orthopedic | Contract sterilization | Jun 28, 2013 |
| HTT | Burr, Orthopedic | Class I | Orthopedic | Contract sterilization | Oct 31, 2012 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract sterilization | Oct 31, 2012 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Oct 31, 2012 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | Apr 17, 2013 |
| HWT | Template | Class I | Orthopedic | Contract sterilization | Jul 17, 2013 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract sterilization | May 3, 2013 |
| ILO | Pack, Hot Or Cold, Water Circulating | Class II | Physical medicine | Contract sterilization | Apr 23, 2013 |
| IOY | Support, Arm | Class I | Physical medicine | Contract sterilization | Mar 19, 2013 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract sterilization | Jun 28, 2013 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | Contract sterilization | Nov 13, 2020 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract sterilization | Jun 20, 2017 |
| IZQ | Injector, Contrast Medium, Automatic | Class II | Cardiovascular | Contract sterilization | Jun 8, 2026 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract sterilization | Apr 23, 2013 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract sterilization | Mar 20, 2013 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Apr 18, 2013 |
| JDS | Nail, Fixation, Bone | Class II | Orthopedic | Contract sterilization | May 21, 2026 |
| JDZ | Mixer, Cement, For Clinical Use | Class I | Orthopedic | Contract sterilization | Oct 29, 2012 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class II | Clinical chemistry | Contract sterilization | Mar 21, 2013 |
| JOH | Tube Tracheostomy And Tube Cuff | Class II | Anesthesiology | Contract sterilization | Mar 22, 2017 |
| JOS | Electrode, Electrosurgical | Class II | General and plastic surgery | Contract sterilization | Apr 23, 2013 |
| JRM | Freezer | Class I | Clinical chemistry | Contract sterilization | Apr 23, 2013 |
| KBJ | Curette, Adenoid | Class I | Ear, nose and throat | Contract sterilization | Jun 28, 2013 |
| KCG | Dilator, Tracheal | Class I | Ear, nose and throat | Contract sterilization | Apr 26, 2017 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General hospital | Contract sterilization | Nov 22, 2022 |
| KCY | Tourniquet, Pneumatic | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| KDC | Instrument, Surgical, Disposable | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract sterilization | May 13, 2009 |
| KDG | Chisel (Osteotome) | Class I | General and plastic surgery | Contract sterilization | Mar 16, 2018 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | Class II | Gastroenterology and urology | Contract sterilization | Oct 30, 2012 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Feb 26, 2018 |
| KGX | Tape And Bandage, Adhesive | Class I | General hospital | Contract sterilization | Nov 12, 2012 |
| KJF | System, Suspension, Cell Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KKX | Drape, Surgical, Antimicrobial | Class II | General and plastic surgery | Contract sterilization | Apr 18, 2013 |
| KMF | Bandage, Liquid | Class I | General hospital | Contract sterilization | May 30, 2013 |
| KMK | Device, Intravascular Catheter Securement | Class I | General hospital | Contract sterilization | May 7, 2013 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Dec 17, 2012 |
| 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 | Apr 23, 2013 |
| KQZ | Component, Traction, Non-Invasive | Class I | Orthopedic | Contract sterilization | Nov 15, 2012 |
| KSB | Set, Transfer (Blood/Plasma) | Class II | Hematology | Contract sterilization | Nov 13, 2012 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Class II | Hematology | Contract sterilization | Nov 13, 2012 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract sterilization | May 13, 2013 |
| KXG | Applicator, Absorbent Tipped, Sterile | Class I | General hospital | Contract sterilization | May 2, 2013 |
| KYW | Container, Liquid Medication, Graduated | Class I | General hospital | Contract sterilization | Nov 15, 2012 |
| LGZ | Warmer, Thermal, Infusion Fluid | Class II | General hospital | Contract sterilization | Feb 28, 2018 |
| LHC | Warmer, Irrigation Solution | Class I | Physical medicine | Contract sterilization | Apr 23, 2013 |
| LHI | Set, I.V. Fluid Transfer | Class II | General hospital | Contract sterilization | Apr 23, 2013 |
| LKB | Pad, Alcohol, Device Disinfectant | Unclassified | General hospital | Contract sterilization | Aug 23, 2013 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Class II | Radiology | Contract sterilization | Jun 29, 2016 |
| LPZ | Container, Frozen Donor Tissue Storage | Unclassified | General hospital | Contract sterilization | Nov 30, 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 | Apr 23, 2013 |
| LYU | Accessory, Surgical Apparel | Class I | General and plastic surgery | Contract sterilization | Jun 20, 2017 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Apr 19, 2013 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Apr 25, 2013 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Oct 31, 2012 |
| 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 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unclassified | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| MHW | Dressing, Compression | Class I | General hospital | Contract sterilization | Oct 29, 2012 |
| MOS | Coil, Magnetic Resonance, Specialty | Class II | Radiology | Contract sterilization | May 1, 2013 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | Class II | Obstetrics and gynecology | Contract sterilization | Oct 31, 2012 |
| MQK | Labware, Assisted Reproduction | Class II | Obstetrics and gynecology | Contract sterilization | Feb 14, 2018 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Apr 23, 2013 |
| MUQ | Glue, Surgical, Arteries | Class III | Cardiovascular | Contract sterilization | Apr 23, 2013 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract sterilization | Nov 22, 2022 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract sterilization | Apr 23, 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 |
| NAY | System, Surgical, Computer Controlled Instrument | Class II | Gastroenterology and urology | Contract sterilization | Apr 23, 2013 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract sterilization | Oct 31, 2012 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | Class II | Ear, nose and throat | Contract sterilization | Oct 31, 2012 |
| NIN | Stent, Renal | Class III | Cardiovascular | Contract sterilization | Dec 10, 2012 |
| NIO | Stent, Iliac | Class III | Cardiovascular | Contract sterilization | Dec 10, 2012 |
| NTB | System, Ablation, Ultrasound And Accessories | Class II | General and plastic surgery | Contract sterilization | Oct 30, 2014 |
| OAF | Implant, Hearing, Active, Middle Ear, Totally Implanted | Class III | Ear, nose and throat | Contract sterilization | Oct 29, 2012 |
| OBJ | Catheter, Ultrasound, Intravascular | Class II | Cardiovascular | Contract sterilization | Jun 28, 2013 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Class II | Gastroenterology and urology | Contract sterilization | Oct 31, 2012 |
| OCW | Endoscopic Tissue Approximation Device | Class II | Gastroenterology and urology | Contract sterilization | Feb 27, 2018 |
| OHO | First Aid Kit Without Drug | Class I | General and plastic surgery | Contract sterilization | Dec 9, 2019 |
| 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 16, 2024 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | Nov 5, 2020 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract sterilization | Oct 16, 2024 |
| PJE | Blood/Plasma Collection Device For Dna Testing | Class II | Clinical chemistry | Contract sterilization | Mar 21, 2013 |
| PJF | Illuminator System For Blood Products | Class III | Hematology | Contract sterilization | Jul 25, 2024 |
| PQE | Ostomy Care Kit | Class I | Gastroenterology and urology | Contract sterilization | Feb 14, 2018 |
| PRJ | Capillary Blood Collection Device For Alternative Site Collection | Class II | Clinical chemistry | Contract sterilization | Aug 31, 2018 |
| PUI | Drape, Surgical, Exempt | Class II | General and plastic surgery | Contract sterilization | Mar 2, 2018 |
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | Class II | General and plastic surgery | Contract sterilization | Nov 5, 2020 |
| QBP | Cap, Device Disinfectant | Class II | General hospital | Contract sterilization | Feb 20, 2020 |
| QCZ | Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator | Class III | Hematology | Contract sterilization | Feb 26, 2021 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | Class II | General hospital | Contract sterilization | May 20, 2025 |
| QPB | System, Suction, Lipoplasty For Removal | Class II | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unclassified | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| QWY | Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator | Class III | Hematology | Contract sterilization | Sep 26, 2024 |