FDA Registration
Active
🇺🇸 United States
Isomedix Operations, Inc
Reg #: 2032098
·
FEI: 3003058448
·
Expires 2026
Products
174
Proprietary Names
355
Establishment Types
2
Classifications
174
Registration Details
- Registration Name
- Isomedix Operations, Inc
- Registration Number
- 2032098
- FEI Number
- 3003058448
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1000 Sarah Pl
- City
- ONTARIO
- State
- CA
- ZIP
- 91761
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2013-01-29 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2020-12-14 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-12-08 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-12-13 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2013-02-11 |
| Container, Frozen Donor Tissue Storage | LPZ | Class U | Unknown | No | 2022-12-05 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2013-01-08 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-11-16 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2019-12-04 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-12-04 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2022-04-24 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2019-12-27 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2012-11-14 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2018-12-05 |
| Board, Arm (With Cover), Sterile | BTX | Class 1 | General, Plastic Surgery | No | 2023-01-24 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2017-07-06 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-01-07 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2020-01-23 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2014-06-17 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2012-12-20 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2024-05-20 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2024-05-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-12-20 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2001-08-06 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2012-12-18 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2017-03-13 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2012-12-20 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2017-12-13 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2018-12-05 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2019-09-25 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2014-09-25 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2012-11-14 |
| Electrical Tumor Treatment Fields | QGZ | Class 3 | Unknown | No | 2023-04-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-05-30 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2017-12-20 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-12-10 |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | Class 2 | Obstetrics/Gynecology | No | 2012-12-20 |
| Cap, Device Disinfectant | QBP | Class 2 | General Hospital | No | 2017-01-04 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2024-05-09 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-12-13 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2017-12-13 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2025-12-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-10-31 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2012-12-20 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2012-12-20 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2020-10-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-11-27 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2012-12-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-12-28 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-06-23 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2012-12-20 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2014-04-01 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2012-11-08 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2014-03-24 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2019-11-17 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-12-20 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2014-04-08 |
| Separator, Automated, Blood Cell And Plasma, Therapeutic | LKN | Class U | Unknown | No | 2015-07-17 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2012-12-27 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2017-09-14 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2020-10-22 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2018-12-02 |
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 2023-07-13 |
| Stimulator, Low Electric Field, Tumor Treatment | NZK | Class 3 | Unknown | No | 2023-02-16 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2012-11-14 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2013-01-30 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2018-08-21 |
| Anterior Staple As Supplemental Fixation For Fusion | PHQ | Class 2 | Orthopedic | No | 2023-06-23 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2013-02-11 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2025-11-21 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2026-03-05 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2016-05-19 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2016-11-22 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2012-12-27 |
| Cord Blood Processing System And Storage Container | OAO | Class 2 | Hematology | No | 2020-11-19 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-11-29 |
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2024-12-04 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2025-08-28 |
| Hood, Surgical | FXY | Class 2 | General, Plastic Surgery | No | 2025-08-28 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2022-01-26 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2019-11-21 |
| System, Suspension, Cell Culture | KJF | Class 1 | Hematology | No | 2013-12-18 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2020-10-07 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2013-01-30 |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2013-01-30 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2013-01-07 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2014-09-25 |
| Screwdriver, Skullplate | GXL | Class 1 | Neurology | No | 2022-11-11 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | Class 2 | General Hospital | No | 2025-08-11 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2012-12-20 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2021-08-26 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2021-08-26 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2021-08-26 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2021-08-26 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2012-12-27 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2023-06-23 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2022-07-30 |
| Needle, Fistula | FIE | Class 2 | Gastroenterology, Urology | No | 2026-03-03 |
| Extractor, Vacuum, Fetal | HDB | Class 2 | Obstetrics/Gynecology | No | 2012-12-20 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2024-07-18 |
| Orthopedic Augmented Reality | SBF | Class 2 | Neurology | No | 2025-12-02 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2012-12-28 |
| Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | SDA | Class 3 | Unknown | No | 2025-08-28 |
| Transducer, Pressure, Intrauterine | HFN | Class 2 | Obstetrics/Gynecology | No | 2012-12-20 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2017-12-13 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2013-02-11 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2012-11-14 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-12-04 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-12-04 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-12-04 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-12-04 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2013-01-28 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2024-02-12 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2026-03-05 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2014-06-18 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2019-11-15 |
| Brush, Biopsy, General & Plastic Surgery | GEE | Class 1 | General, Plastic Surgery | No | 2025-12-03 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2012-11-15 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2022-02-03 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2012-12-28 |
| Wax, Bone | MTJ | Class U | Unknown | No | 2012-12-18 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2021-12-02 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2013-01-29 |
| Duodenoscope And Accessories, Flexible/Rigid | FDT | Class 2 | Gastroenterology, Urology | No | 2024-10-17 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-12-27 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2024-09-16 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2023-04-10 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2012-12-27 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2012-11-08 |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2023-01-20 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 1994-04-11 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-10-23 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2018-12-02 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2020-09-10 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
| Catheter, Urological (Antimicrobial) And Accessories | MJC | Class 2 | Gastroenterology, Urology | No | 2018-06-07 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2012-10-31 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2012-12-28 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2024-09-11 |
| Immunoassay For Detection Of Amniotic Fluid Protein(S). | NQM | Class 1 | Clinical Chemistry | No | 2024-09-11 |
| Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator | QWY | Class 3 | Unknown | No | 2023-10-13 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2013-02-11 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2013-02-11 |
| Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | QDK | Class 2 | Clinical Chemistry | No | 2024-02-12 |
| Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use | QII | Class 2 | Clinical Chemistry | No | 2024-02-12 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2026-03-05 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2026-03-05 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2012-12-27 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2014-07-18 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2020-01-23 |
| Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator | QCZ | Class 3 | Unknown | No | 2019-11-01 |
| Minor Surgical Procedures Tray | PYB | Class 1 | General, Plastic Surgery | No | 2020-03-12 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2023-04-10 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2012-10-31 |
| Stimulator, Nerve, Ac-Powered | BXM | Class 2 | Anesthesiology | No | 2024-09-18 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2012-12-19 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2012-12-27 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2020-05-18 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2020-05-18 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2020-05-18 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2023-05-04 |
| Ear Irrigation Kit | OGQ | Class 1 | General Hospital | No | 2013-01-28 |
Proprietary Names
KeySurgical6941 (LS) - Vascular Loops
Syntech7829 (NT) - The Ahn Tray/ Ahn Tray
Merit1383 (NT,SN) - StayFIX Fixation Device
PFMMedical6614 (TM) - ASEPT Drainage Catheter Dressing Kit (Ref M7041)
Ursel11054 (MN) - TRU-FIX Catheter Fixation Kit
Insulet5490 (NR) - PodPals Adhesive Overlay
Insulet5490 (NR) - Adhesive Overlay
Xenco6850 (NT) - SetX Cervical Interbody System
Xenco6850 (NT) - Xenco Medical Posterior Cervical System
Biogennix6382 (NT) - Agilon
Eagle1350 (NT,SN) - Blackhawk Cervical Spacer System
DJO3655 (NT,LS,LN) - Adaptable, Leg Positioner Disposable Kit
DJO3655 (NT,LS) - Adaptable Arm Positioner Disposable Kit
DJO3655 (NT,LS,LN) - Adaptable, Knee Positioner Disposable Kit
DJO3655 (NT,LS,LN) - Adaptable, UE Disposable Kit
DJO3655 (NT,LS) - Adaptable Retractor Holder Sleeve, 5PK
LSO2556 (NT) - VYCOR VIEWSITE BRAIN ACCESS SYTEM
Avanos2508 (EP1,EP2,NT) - MIC LOW PROFILE GASTROSTOMY TUBE
Avanos2508 (EP1,EP2,NT) - CORFLO* PEG Kit
Eagle1350 (NT,SN) - Acumed Anatomic Radial Head
Eagle1350 (NT,SN) - Bone Screw 3.5mm
SurgicalSpecialties6945 (NT,TM) - Nylon Sutures
Eagle1350 (NT,SN) - Guide Wire
Eagle1350 (NT,SN) - External Fixator
Xenco6850 (NT) - Sorrento Bone Graft Substitute
Eagle1350 (NT,SN) - Octane PEEK Vertebral Body Replacement
Carefusion (EP1) - Gemini/Alaris Pump Module sets
Carefusion5709 (EP1) - Alaris Pump Module SmartSite Low Sorbing Infusion Set
Carefusion (NT) - set, administration, intravascular
UnicareBiomed3455 (NT) Cytoflex mesh
Amphenol15397 (NT) - ITE transducer array
Amphenol15397 (NT) - Novo TTF 100L System
Acumed4864 (NT) - Biotrak Headless Resorbable Compression Screw
Ecomed7308 (LN) - Sureglide
LSO2556 (NT) - C Safe
Carefusion (NT) - Set, administration, intravascular
Eagle1350 (NT,SN) - Cortical Bone Screw
Acumed4864 (NT) - Acutrak 3 Headless Compression Screw System
Eagle1350 (NT,SN) - Orthopaedic Wires
Eagle1350 (NT,SN) - Osteo-Clage Cerclage Cable System
LSO2556 (NT) - Ormco VectorTAS Mini Screw
Biogennix6382 (NT) - OsteoSpan
BeInnovative11045 (LN) - Rotolock Cord Management System
Hydrofera (NR, WH) - Instrument Wipe
SurgicalTech4007 (LS) - FlexiTip, FlexiTip XL, FlexiTip XL-R
Etex2142 (NR) - Precision Cannula 150 mm
PhoenixMed2991 (SP) - Various Instruments
Acuderm1463 (WH,LS) - Acu-Dispo-Ce
PhoenixMed2991 (SP) - Instrument, manual, surgical, general use
Abyrx4508 (WH) - Abyrx Putty Applicator
Protech3048 (TM) - INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Protech3048 (TM) - PHANTOM ML LIGHT CABLE
Design2052 (NR) - CTS Relief Kit
SMC_Amery (LS) - Steripath Micro Blood Collection System
Carefusion5709 (TM) - Gravity Sets
Carefusion5709 (TM) - Medline IV Admin Set
Eagle1350 (NT,SN) - Acumed Scapula Congruent Bone Plate
Merit1383 (SN,NT) - Futura Safety Scalpel
BVI1689 (EP1) - Beaver Sclerotome Blade
BVI1689 (EP1) - Beaver Mini-Blades
BVI1689 (EP1) - Beaver Pocket Blade
BVI1689 (EP1) - BeaverGuard Blade
Eagle1350 (NT,SN) - Bone Plate System
Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 177 mL
Neilmed6807 (NT,SN*) - CVS SALINE NSL MST
Neilmed6807 (NT,SN*) - Nasamist Saline Spray Full Stream, Gentle Stream and Medium Stream
Neilmed6807(NT,SN*) - Nasamist Hypertonic Spray 125ml
Neilmed6807 (NT,SN*) - PediaMist
Neilmed6807 (NT,SN*) - Nasamist Saline Spray Pediatric
Neilmed6807 (NT,SN*) - NasaMist
Neilmed6807 (NT,SN*) - Caring Mill Saline Spray 125 mL
Neilmed6807 (NT,SN*) - CVS Saline Nasal Mist
Neilmed6807 (NT,SN*) - Target Nasal Spray
Neilmed6807 (NT ) - NeilMed Naspira Drops
Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 75 mL
Neilmed6807 (NT,SN*) - NeilMed Nasamist Hypertonic Saline Spray
Neilmed6807 (NT,SN*) - Life Brand Sterile Saline Nasal Mist
Neilmed6807 (NT,SN*) - Himalays Chandra - Neti Spray (Sterile Saline Spray)
Neilmed6807 (NT,SN*) - Himalays Chandra - Neti Spray (Extra Strength Sterile Saline Spray)
Neilmed6807 (NT ) - NeilMed NasaMist Isotonic Saline Spay 125 mL
Neilmed6807 (NT,SN*) - Nasamist All-in-one Saline Spray
Nellcor9073 (NT) - Hollow Laparoscopic Electrode, Flat L-Hook Tip, 28 cm
Nellcor9073 (NT) - Opti4 Hollow Laparoscopic Electrode, Wire J-hook Tip, 28 cm
Acumed4864 (SN,NT) - Acumed Clavicle Hook Plate
Carefusion (EP1,SN,LS,NT) - Alaris Safety Male Luer
Eagle1350 (NT,SN) - Acumed - Radius Rod
BD9423 (MN) - Personal Catheter
BD9423 (MN) - Magic3
BD9423 (NT) - HydroSil
BD9423 (NT) - Hydro Soft
BVI1689 (EP1) - Atomic Edge Knife
BVI1689 (EP1,CH1) - Beaver Micro-Sharp® Blade
BVI1689 (EP1) - Beaver Xstar Knives
BVI1689 (EP1) - Beaver Micro-Unitome Knife
BVI1689 (EP1) - Beaver Sideport MVR Knife
BVI1689 (EP1) - Beaver Optimum Knife
BVI1689 (EP1, CH1)- Beaver Micro-Sharp® Blade
BVI1689 (EP1) - Beaver Swivel Fixation Ring 13mm
BVI1689 (EP1) - Beaver Xstar Safety Slit Knife
BVI1689 (EP1) - CustomEyes
BVI1689 (EP1) - Viscoflow Cannula
Biomeric6631 (LN) - TrabEx
BVI1689 (EP1) - Beaver Xstar Slit Knife
Avanos2508 (NT) - MIC G
Eagle1350 (NT,SN) - Octane Straight Intervertebral Fusion Device
Eagle1350 (SN,NT) - Bulb & Bladder
Amphenol15397 (NT) - INE Transducer Array White
Amphenol15397 (NT) - ILE Transducer Array Large ILE1030
Amphenol15397 (NT) - INE Transducer Array
Amphenol15397 (NT) - ILE Transducer Array Small
Amphenol15397 (NT) - ILE Transducer Array Large
SurgicalSpecialties6945 (NT) - Collagen Plugs
Tyber6592 (WH,CH1) - Tyber Medical PT Interbody Spacer System
Protech3048 (NT) - Continuum ACDF Implant System
Intuitive5779 (NT) - Si Harmonic ACE Insert
Eagle1350 (NT,SN) - Polarus Cap Screw
Merit1383 (SN,NT) - Safeguard Pressure Assisted Dressing (12cm)
Eagle1350 (NT) - TriMed EOS Small Bone Fixation System -Staples & Pins Nitinol Staple
Eagle1350 (NT,SN) - Trimed Nitinol Staple System
Eagle1350 (NT,SN) - Congruent Bone Plate System
Eagle1350 (NT,SN) - Acutrak
SurgicalSpecialties6945 (NT,TM) - Silk Sutures
Eagle1350 (NT,SN) - Acumed - Tension Band Pin
Eagle1350 (NT,SN) - Acumed Small Bone Locking Rod
Biomerics6631 (SN) - T-DOC Urodynamic Catheter
Eagle1350 (NT,SN) - INNate 3.6 system
BVI1689 (EP1) - Extend Synthetic Implants (0.2mm X 2mm)
BVI1689 (EP1) - Extend Synthetic Implants (0.5mm X 2mm)
BVI1689 (EP1) - Extend Synthetic Implants (0.3mm X 2mm)
BVI1689 (EP1) - Extend Synthetic Implants (Variety Pack)
BVI1689 (EP1) - Extend Synthetic Implants (0.4mm X 2mm
Terumo2207 (NT) - Rika Plasma Bottle
Xenco6850 (NT) - SETx Cervical Plate System; Xenco Medical Cervical Plate System
Xenco6850 (NT) - Xenco Medical Cervical Interbody System
Eagle1350 (NT,SN) - Acutrak Plus Fixation System
Neilmed6807 (NT,SN*) - NeilMed Wound Wash
Neilmed6807 (NT,SN*) - NeilMed Piercing After Care
Neilmed6807 (NT,SN*) - NeilMed Wound Wash Piercing after care
Neilmed6807 (NT,SN*) - Neil Cleanse WoundWash Saline Spray
Neilmed6807 (NT,SN*) - NeilCleanse Wash 177 mL
Merit1383 (NT,SN) - TruCut 14Ga
WilsonWolf3589 (LS,LN*) - G-Rex® 100M-CS Cell Culture Product
WilsonWolf3589 (LS,LN*) - G-Rex® 100 Cell Culture Product
WilsonWolf3589 (LS,LN*) - G-Rex® 10 Cell Culture Product
WilsonWolf3589 (LS,LN*) - G-Rex® 10M Open System, Sterile Fluid Path
WilsonWolf3589 (LS,LN*) - G-Rex® 6 Well Plate
WilsonWolf3589 (LS,LN*) - G-Rex® 6M - 2cm2/Well, 6-Well Cell Culture Plate
WilsonWolf3589 (LS,LN*) - G-Rex® 10M-CS Closed System, Sterile Fluid Path
WilsonWolf3589 (LS,LN*) - G-Rex® 24 Well Plate
WilsonWolf3589 (LS,LN*) - G-Rex® 100M-CS Closed System, Sterile Fluid Path
WilsonWolf3589 (LS,LN*) - G-Rex® 6M - 5cm2/Well, 6-Well Cell Culture Plate
WilsonWolf3589 (LS,LN*) - G-Rex® 5M Open System, Sterile Fluid Path
WilsonWolf3589 (LS,LN*) - G-Rex® 100M Cell Culture Product
WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS Cell Culture Product
CorningME1979 (CH1) - Corning Polystyrene Microcarrier beads, Corning Synthemax Microcarrier beads
WilsonWolf3589 (LS,LN*) - G-Rex® 500M-TF Tissue Fragment, Sterile Fluid Path
WilsonWolf3589 (LS,LN*) - G-Rex® 500M, Sterile Fluid Path
WilsonWolf3589 (LS,LN*) - G-Rex® 6M Well Plate
WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS, Closed System, Sterile Fluid Path
WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS, Closed System, Research Use Only
WilsonWolf3589 (LS,LN*) - G-Rex® 50M-TF Research Use Only
Carefusion5709 (EP1) - SEC Set 20DP 30IN w/Hanger LL
Carefusion (TM) - set, administration, intravascular
Carefusion (TM) - (NT) - Secondary Set
Xenco6850 (NT) - CancelleX Cervical Interbody
SpineWave3277 (NT) - Leva Ti PF
Eagle1350 (NT,SN) - Wrist Fusion Plate
Xenco6850 (NT) - CancelleX Porous Titanium Lumbar Interbody Device
Merit1383 (NT,SN,TM) - TruCut 18Ga
Carefusion (EP1) - SmartSite standalone and extension sets
Carefusion5709 (EP1) - Alaris SmartSite Needle-Free Valve
LSO2556 (NT) - Spinous Process Plate
Xenco6850 (NT) - Cancellex Porous Titanium Lumbar Interbody
DermaSci1232 (LN) -MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
Neilmed6807 (NT) - NeilMed Neil Cleanse WoundWash Saline Spray;
Eagle1350 (NT,SN) - Acumed - Bone Graft System
Carefusion (NT) - set, blood transfusion
SurgicalSpecialties6945 (NT) - Gut Sutures
Eagle1350 (NT,SN) - NanoPhix Lag Screw System
Eagle1350 (NT,SN) - TiGer Shark System
Eagle1350 (SN,NT) - Acumed Modular Shoulder System
Nobel6405 (NT) - Replace Select Tapered TiU WP 5x10mm
Nobel6405 (NT) - Easy Abutment NobRpl
Carefusion (NT) - BD Texium Needle-Free Syringe
Smith&Nephew3754 (NR) - (6) Passing Pins, Drill Tip, 2.7mm x 381mm
Smith&Nephew3754 (NR) - 4.5 Incisor
S&N3754 (NR) - Drill, 1.6mm and Guide, Dynomite 2
Smith&Nephew3754 (NR) - Drill, 2.6mm and Guide, Raptormite 3
S&N3754 (NR) - Drill, 3.2mm and Guide, Raptormite 3.7
Smith&Nephew3754 (NR) - Drill, 1.8mm and Guide, Spyromite / Minitac2
Wolfmed8101 (MN) - DIAMOND BURR 3MM WL 350MM ROUND
Protech3048 (NT) - KMTI Bipolar Hip System
Carefusion5709 (NT) - MaxGuard extension set with Y-site(s)
Carefusion5709 (NT) - MaxGuard single dose vial access spike
Carefusion5709 (NT) - MaxPlus presssure rated extension set with needleless connector and y-site
Carefusion5709 (NT) - MaxPlus pressure rated extension set with needleless connector
Carefusion5709 (NT) - MaxGuard pressure rated T-connector extension set
Carefusion5709 (NT) - MaxGuard Extension Set
Carefusion5709 (NT) - MaxPlus, MaxGuard multi-fuse extension set with needleless connector(s)
Carefusion5709 (NT) - MaxGuard pressure rated extension set with Y-site(s)
Carefusion5709 (NT) - MaxGuard extension set with needleless Y-site(s)
Carefusion5709 (NT) - MaxGuard pressure rated T-connector extension set with needleless connector
Carefusion5709 (NT) - MaxPlus, MaxGuard pressure rated T-connector extension set with needleless connector
Carefusion5709 (NT) - MaxPlus Needleless Connector
Carefusion5709 (NT) - MaxGuard, MaxPlus multi-fuse extension set with needleless connector(s)
Carefusion5709 (NT) - MaxPlus Extension Set
Carefusion5709 (NT) - MaxGuard multi-fuse extension set with needleless connector(s)
Carefusion5709 (NT) - MaxGuard pressure rated extension set
Carefusion5709 (NT) - MaxGuard T-connector extension set with needleless connector
Carefusion5709 (NT) - MaxGuard T-connector extension set
Carefusion5709 (NT) - MaxPlus pressure rated extension set with removable needleless connector
Carefusion5709 (NT) - MaxGuard, MaxPlus multi-fuse extension set with needleless connector (s)
Carefusion5709 (NT) - MaxGuard standard needleless connector
Carefusion5709 (NT) - MaxGuard extension set with standard needleless connector
Carefusion5709 (NT) - MaxPlus, MaxGuard T-connector extension set with needleless connector
Carefusion5709 (NT) - MaxGuard multidose vial adaptor
Carefusion5709 (NT) - MaxGuard Extension Set with Filter
Carefusion5709 (NT) - MaxPlus extension set with needleless connector and y-site
Carefusion (NT) - 96"IV GRAVITY SET W/2 NDL FREE Y SITE
Xenco6850 (NT) - Lumbar Interbody System
Xenco6850 (NT) - SETx Lumbar Interbody System
Xenco6850 (NT) - SET ALIF INSERTER
Xenco6850 (NT) - SET PLIF/TLIF/OBLIQUE INSERTER
Xenco6850 (NT) - SET TLIF TAMP
Xenco6850 (NT) - Xenco Medical Lumbar Interbody System
Nobel6405 (NT) - Snappy Abutment
Carefusion (NT,TM) - set, administration, intravascular
Providien2420 (NT) - Soft K-Rette Kylon Wound
Providien2420 (NT) - Soft K-Bride Kylon Wound
LSO2556 (NT) - VYCOR VIEWSITE BRAIN ACCESS SYTEM with ALIGNMENT CLIP
Desco14244 (NT) - STELLAR Knee
StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK-SOFT TISSUE FIXATION
StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK BONE-TENDON-BONE
Zimmer (LN,LS) - Toggleloc
Zimmer (LN,LS) - Maxfire
Acuderm1463 (WH,LS) -Acu-Punch Kit
SurgicalSpecialties6945 (TM,NT) - Polyester Sutures
Avanos2508 (EP1,EP2,NT) - MIC PEG TUBE
Avanos2508 (EP1,EP2,NT) - MIC PEG Kit
Xenco6850 (NT) - SETx Pedicle Screw System
Intuitive5779 (NT) - Stapler Sheath
LSO2556 (NT) - Filler, Bone Void, Calcium Compound
Merit1383 (SN,NT) - PAL - Pen and Labels
KeySurgica6941 (LS) - Sterile Labels
RMAC1276 (WT) - PharmaTags
Eagle1350 (NT,SN) - SLIC Screw
BVI1689 (EP1) - Iris Ring
BVI1689 (EP1) - Iris Ring & Inserter
MicroSurg4751 (BP) - Malyugin RIng
SurgicalSpecialties6945 (NT) - Bone Wax
Neilmed6807 (NT,SN*) - NasaMist - Isotonic
Neilmed6807 (NT) - NeilMed NasaMist Extra Strength (Hypertonic) Saline Spray
Neilmed6807 (NT,SN*) - Ultra Gentle Spray
Neilmed6807 (NT,SN*) - Walgreen Nasal Mist
Neilmed6807 (NT) - Walgreens Nasal Mist
Neilmed6807 (NT) - NeilMed SinuHale
Carefusion (LS,NT) - SmartSite Stopcock
Zimmer (LN,LS) - Bit, drill
StrykerPR3324 (GR, LS, VG) - Twinloop FLEX TM Drill
StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX
Zimmer (LN,LS) - Cannulated toggle button drill 4.5 MM
Eagle1350 (NT,SN) - Drill
OmegaSurgical (LSRTC) - BIT, DRILL
OrchidUnique5936 (LN) - Bit, Drill - Omega
SurgicalSpecialties6945 (NT) - Surgical Knives
Carefusion (LS,NT) - Gravity Burette Sets
Protech3048 (TM) - Vampiro
Avanos2508 (EP1,EP2,NT) -MIC-KEY G
Avanos2508 (EP1,EP2,NT) - MIC and MIC-KEY G-Tube and Extension Sets
Eagle1350 (NT,SN) - Bone Plate
Eagle1350 (NT,SN) - Stableloc II External Fixator
Merit1383 (SN, NT) - Medallion Syringe
Merit1383 (SN, NT) - K01 Syringe Kit (MSS)
Eagle1350 (NT,SN) - Silverbolt MIS Mainframe HA Screw System
Ensera7760 (SP) - ClarifEye Markers
WolfX-Ray11781 (SP) - Steritatt
Eagle1350 (NT,SN) - Depth Gauge
Biogennix6382 (NT) - Sypher ALIF Spacer System
Carefusion5709 (TM) - Alaris Extension Set-
Merit1383 (SN) - SafeGuard Focus Compression
Merit1383 (SN) - ShortStop Temporary Sharps Holder
Merit1383 (TM) - BackStop Plus Closed Waste Basin
Merit1383 (SN) - ShortStop Advantage Temporary Sharps Holder
Merit1383 (NT,SN) - ShortStop Advantage Temporary Sharps Holder
Ranfac3098 (NR) - SS-1529, Hypodermic Needle, S-115
BVI1689 (CH1,EP1) - Retrobulbar
BVI1689 (EP1, CH1) - Peribulbar
Clearside6394 (MN,SP) - SCS Microinjector
Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM
BD1686 (NT) - Magic 3
BD1686 (NT) - Personal
Avanos2508 (NT) - Halyard
Avanos2508 (NT) - TRACH CARE TRACHEAL SUCTION SYSTEM
Avanos2508 (NT) - KimVent Closed Suction System
Xenco6850 (NT) - SetX Pedicle Screw System
Xenco6850 (NT) - Xenco Medical Pedicle Screw System
Carefusion (EP1,SN,LS,NT) - Secondary Sets with Shrouded Needle
Acumed4864 (NT) - Ankle Plating System 3
Eagle1350(NT,SN) - INNate 4.5 System
Avita6412 (NT,BP) - RECELL
Nellcor9073 (NT) - Covidien LLC
Xenco6850 (NT) - SETx Cervical Interbody System
Protech3048 (NT) - BonVie+
Globus4330 (GR,NT*) - NuVasive NVJJB System
Eagle1350 (NT,SN) - Cerclage Wire Crimp Sleeve
Eagle1350 (NT,SN) - Ascendant Cervical Spacer System
Merit1383 (TM) - RoVo Mechanical Thrombectomy Catheter
Biogennix6382 (NT) - Morpheus; PURcore; MAC-Fuse
Eagle1350 (NT,SN) - ArcPhix system
Carefusion5709 (NT) - MaxZero multi-fuse extension set with needleless connector(s)
Carefusion5709 (NT) - MaxZero multi-fuse pressure rated extension set with needleless connector(s)
Xenco6850 (NT) - Cervical Interbody System
Xenco6850 (NT) - Argus Cervical Interbody System;
Xenco6850 (NT) - Cervical Tamp (SS)
Xenco6850 (NT) - Cervical Plate Holder (SS)
Eagle1350 (NT,SN) - Tomcat Cervical Spinal System
Avita6412 (BP,NT) - RECELL
PFMMedical6614 (TM) - ASEPT Procedure Pack (Ref M7040)
Merit1383 (SN, NT) - K13 Label Kit
PFMMedical6614 (TM) - Jet-Vac
Amphenol15397 (NT) - Tissue Collection
Acumed4864 (NT) - Acumed Hand Plating System
Carefusion (NT,LS) - set, administration, intravascular; set, I.V., fluid transfer
Carefusion5709 (TM) - Alaris Medical Infusion System Administration Sets-
Avanos2508 (NT) - Neonatal Percussor
Merit1383 (SN,NT) - Safeguard Radial Compression Device
Xenco6850 (NT) - Multilevel CerviKit
MicroSurg4751 (SN,NT) - MST Phaco Tips
Merit1383 (SN,NT) - Safeguard Pressure Assisted Device 24 cm
Xenco6850 (NT) - Sorrento Bone Graft Substitute
Anodyne3068 (LN, LS) - PEYMAN
BVI1689 (EP1) - Soft Tip Cannula
BVI1689 (EP1) - LASIK Irrigating Cannula
BVI1689 (EP1) - Flexible Tip Cannula
BVI1689 (EP1) - Visitec Nucleus Hydrodissector
BVI1689 (EP1) - Micro J Shape Cannula
BVI1689 (EP1) - Irrigating Cystotome
BVI1689 (EP1) - Anterior Chamber Cannula [Rycroft]
BVI1689 (EP1) - Cortical Cleaving Hydrodissector
BVI1689 (EP1) - Infusion Cannulas
BVI1689 (EP1) - Lacrimal Cannula
SonomedEscalon8890 (MN) - Viscous Fluid Cannula
Eagle1350 (NT,SN) - Aculoc 2 Extension Plate
Eagle1350 (NT,SN) - Cannulated Cancellous Bone Screw
Merit Medical (SN,NT) - Arcadia Balloon Catheter
Eagle1350 (NT,SN) - InFrame System
Carefusion (NT) - Texium Closed Male Luer
Eagle1350 (NT,SN) - Octane Straight Intervertebral Fusion Device, Ti Coated
SurgicalSpecialties6945 (NT) - Surgical Blades
Carefusion (NT) - BD SmartSite Needle-Free Valve Alaris Products
Neilmed6807 (NT) - NeilMed PediaMist
Neilmed6807 (NT) - NeilMed NasaMist
Neilmed6807 (NT) - NeilMed NasaMist Hypertonic Saline Spray 125mL
Carefusion (EP1,SN,LS,NT) - PrimeSaver Sets (Ball Valve)
Neilmed6807 (NT) - NeilMed Clear Canal Earwax Complete Removal Kit - All Natural
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Device in the United States for Export Only