FDA Registration
Active
🇺🇸 United States
Isomedix Operations, Inc.
Reg #: 2030624
·
FEI: 3000206435
·
Expires 2026
Products
195
Proprietary Names
415
Establishment Types
2
Classifications
195
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 2030624
- FEI Number
- 3000206435
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 43425 Business Park Dr
- City
- Temecula
- State
- CA
- ZIP
- 92590
- 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 |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2015-08-20 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-08-16 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2020-03-07 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2018-04-19 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2022-04-24 |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | Class 2 | Gastroenterology, Urology | No | 2020-01-13 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2020-01-13 |
| Accessories, A-V Shunt | KNZ | Class 2 | Gastroenterology, Urology | No | 2020-01-13 |
| Prosthesis, Wrist, Hemi-, Ulnar | KXE | Class 2 | Orthopedic | No | 2024-08-12 |
| Stent, Urethral, Prostatic, Permanent Or Semi-Permanent | MER | Class 3 | Unknown | No | 2026-03-13 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2020-03-08 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2019-12-10 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2020-03-08 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2015-12-28 |
| Pump, Infusion, Elastomeric | MEB | Class 2 | General Hospital | No | 2022-04-24 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2024-08-26 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2024-08-26 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2020-12-08 |
| Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | OJX | Class 3 | Unknown | No | 2024-08-26 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2024-08-26 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2012-12-28 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2024-10-15 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2019-12-27 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2024-11-04 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2012-12-27 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2020-01-13 |
| Percutaneous Catheter, Ultrasound | PPN | Class 2 | Cardiovascular | No | 2025-12-02 |
| Retainer, Surgical | GCZ | Class 1 | General, Plastic Surgery | No | 2023-04-20 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2015-09-03 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-12-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-12-22 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-12-22 |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | Class 2 | Gastroenterology, Urology | No | 2020-01-13 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2024-10-15 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Catheter, Femoral | LFK | Class 2 | Gastroenterology, Urology | No | 2020-01-13 |
| Catheter, Subclavian | LFJ | Class 2 | Gastroenterology, Urology | No | 2020-01-13 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2026-01-06 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2017-11-08 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2026-01-06 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2020-04-30 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2012-11-01 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2024-08-12 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2024-10-18 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2019-12-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2023-02-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-02-09 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2012-12-18 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-01-13 |
| Monitor, Pressure, Intracompartmental | LXC | Class U | Unknown | No | 2024-01-03 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2013-01-28 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2026-01-05 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-12-09 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2012-11-14 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2020-11-18 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2024-10-15 |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2020-12-15 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2022-06-30 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-06-30 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-06-30 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2020-04-30 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2020-01-13 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-08-16 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-08-16 |
| Pacemaker Lead Adaptor | DTD | Class 2 | Cardiovascular | No | 2024-08-21 |
| Fluid Jet Removal System | PZP | Class 2 | General, Plastic Surgery | No | 2025-02-17 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2020-01-13 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2024-08-12 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-12-13 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2024-08-13 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2020-01-13 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2020-01-13 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2023-05-19 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2023-05-19 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2023-04-20 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2023-12-20 |
| Intravenous Extension Tubing Set | OJA | Class 2 | General Hospital | No | 2018-09-24 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2020-11-18 |
| Kit, Repair, Catheter, Hemodialysis | NFK | Class 2 | Gastroenterology, Urology | No | 2020-03-07 |
| Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | PQK | Class 2 | Cardiovascular | No | 2020-01-31 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2014-06-20 |
| Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) | PZK | Class 3 | Ophthalmic | No | 2018-12-20 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2020-12-15 |
| Gases Used Within Eye To Place Pressure On Detached Retina | LPO | Class 3 | Ophthalmic | No | 2025-11-25 |
| Universal Drainage Tray | PPD | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-11-16 |
| Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation | QPY | Class 3 | Unknown | No | 2024-08-27 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2024-08-16 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2024-08-16 |
| Midline Catheter | PND | Class 2 | General Hospital | No | 2020-03-11 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2012-12-28 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2019-06-07 |
| Graft, Vascular, Stainless Steel Tunneler | MZY | Class 2 | Cardiovascular | No | 2020-01-13 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2025-01-03 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2020-11-16 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2014-03-03 |
| Implant, Cochlear | MCM | Class 3 | Unknown | No | 2024-08-27 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2020-01-13 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2013-01-17 |
| Stent Graft, Bypass, Superficial Femoral Artery | QWM | Class 3 | Unknown | No | 2025-11-21 |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | Class 2 | General, Plastic Surgery | No | 2023-04-06 |
| 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, 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 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2024-08-27 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-08-16 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-03-10 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2012-12-28 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-05-02 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2024-09-16 |
| Device, Thermal Ablation, Endometrial | MNB | Class 3 | Unknown | No | 2023-04-19 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2022-04-24 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2022-12-26 |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2024-08-27 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2024-08-16 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2018-10-24 |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | Class 2 | Neurology | No | 2024-08-16 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2014-09-25 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2023-04-05 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2026-01-05 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2012-12-27 |
| Heart-Valve, Non-Allograft Tissue | LWR | Class 3 | Unknown | No | 2021-02-02 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2020-10-22 |
| Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | OHV | Class 2 | General, Plastic Surgery | No | 2023-03-21 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2024-08-27 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2024-08-21 |
| Device, Iontophoresis, Other Uses | EGJ | Class 2 | Physical Medicine | No | 2024-08-16 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Minor Surgical Procedures Tray | PYB | Class 1 | General, Plastic Surgery | No | 2020-03-12 |
| Catheter Introducer Kit | OFC | Class 2 | Cardiovascular | No | 2013-01-28 |
| Absorbable Lung Biopsy Plug | OMT | Class 2 | General, Plastic Surgery | No | 2024-04-01 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2026-03-13 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2022-04-19 |
| Catheter, Septostomy | DXF | Class 2 | Cardiovascular | No | 2025-11-24 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2024-08-27 |
| Apparatus, Suction, Patient Care | DWM | Class 2 | Cardiovascular | No | 2023-04-06 |
| Powered Insertion System For A Cochlear Implant Electrode Array | QQH | Class 2 | Ear, Nose, Throat | No | 2022-10-20 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-11-16 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-08-12 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2020-09-10 |
| Stethoscope, Esophageal, With Electrical Conductors | BZT | Class 2 | Anesthesiology | No | 2020-11-16 |
| Peritoneal Dialysis Administration Kit | PPJ | Class 2 | Gastroenterology, Urology | No | 2020-03-20 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2012-12-27 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2018-04-27 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2025-01-17 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2012-12-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-04-20 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2012-12-28 |
| Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered | PUL | Class 2 | Ophthalmic | No | 2023-01-21 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | Class 2 | Gastroenterology, Urology | No | 2024-09-23 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-12-28 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2022-12-26 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2018-02-23 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Monitor, Electric For Gravity Flow Infusion Systems | FLN | Class 2 | General Hospital | No | 2023-07-05 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2014-04-01 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-02-24 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2024-08-16 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2024-08-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2024-08-16 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2024-08-16 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2014-04-09 |
| Device, Patient Transfer, Powered | FRZ | Class 2 | General Hospital | No | 2020-08-06 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2020-10-15 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2024-07-09 |
| Peripheral Temporary And Retrievable Stent System | SEU | Class 2 | Cardiovascular | No | 2025-11-24 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 1996-09-09 |
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2025-01-07 |
| Oximeter, Reprocessed | NLF | Class 2 | Cardiovascular | No | 2012-12-28 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2012-12-28 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2021-12-20 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2013-12-18 |
| Ablation Catheter, Renal Denervation | QYI | Class 3 | Unknown | No | 2023-11-16 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2024-08-21 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2025-05-23 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2012-11-07 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2023-08-09 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2023-08-09 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2023-08-09 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2023-08-09 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2024-08-12 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2024-08-12 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2024-08-12 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2014-03-03 |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2023-01-20 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2024-08-16 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2012-10-31 |
| Reprocessed Bronchoscope | QNW | Class 2 | Ear, Nose, Throat | No | 2024-01-17 |
Proprietary Names
Merit1383 (TM) - Fluid Administration Set (FAS)
Merit1383 (TM) - CT Transfer
Merit1383 (TM) - PreludeSYNC Radial Compression Device
Merit1383 (TM) - PreludeSYNC Distal Radial Compression Device
Avanos2508 (TM) - EchoBright Echogenic PNB Needle
Avanos2508 (TM) - EchoBright Echogenic Regional Block Needle with Injection Set
Zenflow34605 (TM) - Zenflow Spring Implant and Delivery System
Merit1383 (TM) - SafeSheath Sealing Adapter
Biomerics6631 (LN) - StandTall
Merit1383 (TM) - NeoVasc
Avanos2508 (TM) - SELECT-A-FLOW*
Avanos2508 (TM) - I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
VerathonMedical5877 (TM) - GlideScope BFlex 5.8 Sinlge-Use Bronchoscope System
VerathonMedical5877 (TM) - GlideScope BFlex 5.8 Single-Use Bronchoscope System
VerathonMedical5877 (TM) - GlideScope BFlex 2 Large 5.8 Single-Use Bronchoscope
Protech3048 (TM) - Vein Pick
Protech3048 (TM) - Slit Suture Sleeve
Atrium1623 (NR) - Chest Drain Accessories
Ursel11054 (MN) - Thora-Vent Thoracic Vent
PFMMedical6614 (TM) - Asept; Jet-Vac
LSO2556 (TM) - SurgiFish Viscera Retainer
Merit1383 (TM) - Disposal Depot (MDD)
Acumed4864 (TM) - Acu-Sinch Knotless
SurgicalSpecialties6945 (TM) - Barbed PPN Sutures
Carefusion (EP1) - SmartSite standalone and extension sets
Carefusion5709 (EP1) - Alaris SmartSite Needle-Free Valve
Carefusion5709 (TM) - Medline IV Admin Set
Carefusion (NT) - set, administration, intravascular
Ursel11054 (MN) - Optimus
Merit1383 (TM) - Merit Drainage Depot
Merit1383 (TM) - Merit MAK
Merit1383 (TM) - Corvocet Coaxial Introducer
Merit1383 (TM) - Finale Radial Compression System
DVL-Op6436 (TM) - BRCDXL-05 Breast Reduction Compression Device XL
DVL-Op6436 (TM) - BRCD-05 Breast Reduction Compression Device
Merit1383 (TM) - RADstat Radial Artery Compression Device
PrecisionMedical (NR) - T-RING
Carefusion5709 (TM) - Gravity Sets
Carefusion (NT) - Set, administration, intravascular
Merit1383 (TM) - Prelude Prestige Splittable Sheath Introducer
DVL-op6436 (TM) - Motiva Channel Separator
Carefusion5709 (EP1) - SEC Set 20DP 30IN w/Hanger LL
Carefusion (TM) - set, administration, intravascular
Carefusion (TM) - (NT) - Secondary Set
SurgicalSpecialties6945 (NT,TM) - Nylon Sutures
Protech3048 (TM) - MY01-0001 MY01 Continuous Compartmental Pressure Monitor
Merit1383 (TM) - Dilators
Pretium1202 (WT) - Leakbuster
PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag with Procedure Pack (Ref 622281)
PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag (Ref 622280)
Merit1383 (SN) - Cultura Saliva Self Collection Kit
PFMMedical6614 (TM) - ASEPT 2,000mL Drainage Bag (Ref M7058)
PFMMedical (TM) - ASEPT 2,000mL Drainage Bag with Procedure Pack (Ref M7060)
CorningME1979 (CH1) - Corning Closed Systems individually wrapped centrifuge tubes and accessories
BD4590 (SP) - BD Vacutainer® No Additive (Z) Plus Tubes
LSO2556 (TM) - RFA-06022 Sonata Radiofrequency Ablation Handpiece
Merit1383 (TM) - Corvocet Biopsy System
Protech3048 (TM) - Falcon
Protech3048 (TM) - IS-1/Quadripolar Terminal Cap
Protech3048 (TM) - Stylet Kit
Protech3048 (TM) - Stylet Model 4078
LSO2556 (TM) - SeromaCath Wound Drainage System
LSO2556 (TM) - Sapphire Suction Reservoir
Carefusion (NT,LS) - set, administration, intravascular; set, I.V., fluid transfer
Carefusion5709 (TM) - Alaris Medical Infusion System Administration Sets-
Merit1383 (TM) - K04 - Tubing Kit
Merit1383 (TM) - K08- Fluid Management Kit
Biophyx13655 (LN) - RETRACTOR
DVL-opMEDICO6436 (TM) - RetraLight
Merit1383 (TM) - Temno Evolution
Merit1383 (TM) - K05 Inflation Kit
SurgicalSpecialties6945 - (TM) DURAMESH Mesh Suture
Avenu7784 (TM) - Ellipsys Vascular Access System
Medtronic2686 (MN) - Ellipsys® Vascular Access System (Catheter)
Protech3048 (TM) - MicoTransponder Vivistim Paired VNS System (Vivistim System)
PFMMedical (TM) - 4F x 20cm Single Lumen Midline (Ref PFM4SML20N)
PFMMedical (TM) - 5F x 20cm Single Lumen Midline (Ref PFM5SML20)
PFMMedical (TM) - 3F x 20cm Single Lumen Midline (Ref PFM3SML20N)
PFMMedical (TM) - 5F x 20cm Dual Lumen Midline (Ref PFM5DML20)
PFMMedical (TM) - 3F x 20cm Single Lumen Midline (Ref PFM3SML20)
PFMMedical (TM) - 4F x 20cm Single Lumen Midline (Ref PFM4SML20)
Merit1383 (TM) - Vessel Sizing Catheter (VSC)
Protech3048 (TM) - Superhawk
Protech3048 (TM) - Mustang
Protech3048 (TM) - Eagle
VerathonMedical5877 (TM) - GlideScope BFlex Sinlge-Use Bronchoscope System
VerathonMedical5877 (TM) - GlideScope BFlex 5 Single-Use Bronchoscope System
VerathonMedical5877 (TM) - GlideScope BFlex 2 Regular 5 Single-Use Bronchoscope
PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Nursing Kit (Ref PFM2CT3SP)
PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC (Ref: PFM2CT3S)
PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC SV OTW Kit (Ref PFM2CT3SR)
PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Kit (Ref PFM2CT4DW)
PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Nursing Kit (Ref PFM2CT4DP)
PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Nursing Kit (Ref: PFM2CT4DN)
PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Nursing Kit (Ref: PFM2CT3SN)
PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC SV OTW Kit (Ref PFM2CT4DR)
PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC OTW Kit (Ref: PFM2CT3SL)
PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Kit (Ref PFM2CT3SW)
PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC (Ref: PFM2CT4D)
AbbotVasc (TM) - Dragonfly OpStar Imaging
Merit1383 (TM) - Hydrophillic Prelude SNAP Splittable Sheath Introducer
Puregraft8291 (TM) - Dermapose Refresh
Protech3048 (TM) - PHANTOM ML LIGHT CABLE
Remington4376 (SP) - Illumination Systems
Protech3048 (TM) - AIM Sterile Inserts
Olympus2295 (MN) - Uro Guide
Merit1383 (TM) - DriPAD Super Absorbent Pad
SurgicalSpecialties6945 (NT,TM) - Silk Sutures
Protech3048 (TM) - Hex Wrench
Protech3048 (TM) - Torque Driver
Protech3048 (TM) - IS-1 Receptacle Plus
Protech3048 (TM) - IS4/DF4 Port Plug Accessory Kit
Protech3048 (TM) - Lead Cap (IS1/DF1/SJ4)
Protech3048 (TM) - DF-1 Receptacle Plug
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
Spineology5627 (MN) - E Blades/Rakes
Spineology5627 (MN) - SOAR Portal Tubes
Protech3048 (TM) - Metaphyseal Kit, 5 Pack
Spineology5627 (MN) - Retractor
Protech3048 (TM) - Diaphyseal Kit, Single
Spineology5627 (MN) - Duo Disposable Instruments
Protech3048 (TM) - Universal Pin in Place Guide
Protech3048 (TM) - Diaphyseal Kit, 5 Pack
Merit1383 (TM) - SafeSheath CSG Introducer Sheath Kit
BVI1689 (EP1) - Iris Ring
BVI1689 (EP1) - Iris Ring & Inserter
MicroSurg4751 (BP) - Malyugin RIng
Natus2422 (TM) - Micro Ventricular Bold Pressure/Temperature Monitoring Kit, MOdule 110-4HMT
Kurin7497 (TM) - Kurin Blood Culture Collection Set
Avanos2508 (TM) - ProBloc, HN Series and Prolong, PL Series
SurgicalSpecialties6945 (TM) - PCL Punctum Plugs
Protech3048 (TM) - Suture Sleeve Accessory DS2A088
Merit1383 (TM) - 5.5F Worley Advanced LVI Lateral Vein Introducer
SurgicalSpecialties6945 (TM) - Silicone Punctum Plugs
Dravon8000 (TM) - BLUE T-CLAMP
PFMMedical6614 (TM) - 6F x 60cm Triple Lumen CT PICC Nursing Kit (Ref: PFM2CT6TN)
PFMMedical6614 (TM) - 6F x 60cm Triple Lumen CT PICC OTW Kit (Ref: PFM2CT6TL)
PFMMedical6614 (TM) - 6F x 60cm Triple Lumen CT PICC (Ref: PFM2CT6T)
PFMMedical6614 (TM) - 6F x 60cm Triple Lumen CT PICC Kit (Ref PFM2CT6TW)
PFMMedical6614 (TM) - 5F x 55cm Triple Lumen CT PICC OTW Kit (Ref: PFM2CT5TL)
PFMMedical6614 (TM) - 5F x 55cm Triple Lumen CT PICC (Ref: PFM2CT5T)
PFMMedical6614 (TM) - 5F x 55cm Triple Lumen CT PICC Nursing Kit (Ref: PFM2CT5TN)
PFMMedical6614 (TM) - 5F x 55cm Triple Lumen CT PICC Kit (Ref PFM2CT5TW)
SurgicalSpecialties6945 (TM,NT) - Polyester Sutures
Merit1383 (TM) - Temno ACT
Merit1383 (TM) - Temno Original
MPS34520 (TM) - BTF-HM-3, Hummingbird Trifurcated Extension Se
Natus2422 (TM) - Micro Ventricular Bolt Pressure Monitoring Kit, Model 110-4HM
Carefusion5709 (TM) - MSIII Administration Sets
Carefusion5709 (TM) - MSIII HALF DEHP SMBORE INJ
Carefusion5709 (TM) - MedSystem III Infusion Se
Protech3048 (TM) - Spirit
Zeiss34518 (TM) - Intraocular Lenses
Merit1383 (TM) - ReSolve Biliary Locking Drainage Catheter
AccessSci5463 (TM) - POWERWAND XL 3Fr X 6cm, Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - PW ED 3Frx6cm, Safety Introducer w/Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND XL 3Fr X 6cm, Extended Dwell Catheter
Protech3048 (TM) - Nighthawk
PFMMedical6614 (TM) - Scripps 5F x 10cm Jet-Vac Procedure Trays (Ref: M7854SC)
PFMMedical6614 (TM) - 4F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613211)
PFMMedical6614 (TM) - Palomar 5F x 7cm Jet-Vac Procedure Trays (Ref M7853P)
Ranfac3098 (NR) - GIU-30, 31G-END, 30G-END, GIU-31
PFMMedical6614 (TM) - 5F x 15cm Jet-Vac Centesis Catheter (Ref M7515)
PFMMedical6614 (TM) - 4F x 7cm Jet-Vac Centesis Catheter (Ref M7511)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Safety Procedure Tray (Ref M7554NM)
PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Centesis Catheter (Ref M7512)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Safety Procedure Tray (Ref M7554)
Merit1383 (TM) - Mak-NV
PFMMedical6614 (TM) - Palomar 5F x 10cm Jet-Vac Procedure Trays (Ref M7854P)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Centesis Catheter (Ref M7514)
PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Safety Procedure Tray (Ref M7553)
PFMMedical6614 (TM) - 5F x 15cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613214)
PFMMedical6614 (TM) - Eisenhower 5F x 7cm Jet-Vac Procedure Tray (Ref M7853EI)
PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Centesis Catheter (Ref M7513)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Procedure Tray (Ref M7854)
PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Safety Procedure Tray (Ref M7552)
PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Procedure Tray (Ref 850007)
PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Procedure Tray (Ref M7853)
PFMMedical6614 (TM) - Eisenhower 5F x 10cm Jet-Vac Procedure Tray (Ref M7854EI)
PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Procedure Tray (Ref M7852)
PFMMedical6614 (TM) - 4F x 7cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613210)
Ranfac3098 (NR) - Sialography Unit Endport
PFMMedical6614 (TM) - 5F x 7cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613212)
Merit1383(TM) - Introducer Needle with Trocar Stylet,
PFMMedical6614 (TM) - 5F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613213)
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) - Viscoflow Cannula
BVI1689 (EP1) - Cortical Cleaving Hydrodissector
BVI1689 (EP1) - Infusion Cannulas
BVI1689 (EP1) - Lacrimal Cannula
SonomedEscalon8890 (MN) - Viscous Fluid Cannula
Merit1383 (TM) - Pink Achieve
Merit1383 (TM) - Achieve
EdwardsLife6723 (TM) - MITRIS RESILIA Mitral Valve
EdwardsLife6723 (MN,TM) - KONECT RESILIA Aortic Valved Conduit
AtriCure2121 (SP) - AtriCure Dissector
Protech3048 (TM) - Initia Total Hip System
Protech3048 (TM) - Medical Adhesive
SurgicalSpecialties6945 (TM) - PGA Sutures
Merit1383 (TM) - Prelude Sheath Introducer
MPS34520 (TM) - BTF-HM-3, DB-003-03, EA-036-01, EB-006-11, EB-012-01, EB-030-02, EB-030-13, EB-038-02
MPS34520 (TM) - EC-072-01, EG-013-01, EG-016-04, EH-047-01, KMI-02-06, KMI467C, KMI483C, KMI636
MPS34520 (TM) - EB-038-11, EB-045-03, EB-060-01, EB-060-27, EB-072-01, EB-072-02, EB-072-03, EB-112-01, EC-060-01
SurgicalSpecialties6945 (TM) - Barbed PDO Sutures
PFMMedical6614 (TM) - 6F x 60cm Dual Lumen CT PICC Nursing Kit (Ref: PFM2CT6DN)
PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC Nursing Kit (Ref PFM2CT4SP)
PFMMedical6614 (TM) - 5F x 55cm Single Lumen CT PICC Kit (Ref PFM2CT5SW)
PFMMedical6614 (TM) - 6F x 60cm Dual Lumen CT PICC Kit (Ref PFM2CT6DW)
PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC OTW Kit (Ref: PFM2CT4SL)
PFMMedical6614 (TM) - 5F x 55cm Dual Lumen CT PICC OTW Kit (Ref: PFM2CT5DL)
PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC Kit (Ref PFM2CT4SW)
PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC (Ref: PFM2CT4S)
PFMMedical6614 (TM) - 6F x 60cm Dual Lumen CT PICC OTW Kit (Ref: PFM2CT6DL)
PFMMedical6614 (TM) - 5F x 55cm Dual Lumen CT PICC Nursing Kit (Ref: PFM2CT5DN)
PFMMedical6614 (TM) - 5F x 55cm Single Lumen CT PICC Nursing Kit (Ref: PFM2CT5SN)
PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC SV OTW Kit (Ref PFM2CT4SR)
PFMMedical6614 (TM) - 5F x 55cm Single Lumen CT PICC OTW Kit (Ref: PFM2CT5SL)
PFMMedical6614 (TM) - 5F x 55cm Dual Lumen CT PICC (Ref: PFM2CT5D)
PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC Nursing Kit (Ref: PFM2CT4SN)
PFMMedical6614 (TM) - 5F x 55cm Dual Lumen CT PICC Kit (Ref PFM2CT5DW)
PFMMedical6614 (TM) - 5F x 55cm Single Lumen CT PICC (Ref: PFM2CT5S)
PFMMedical6614 (TM) - 6F x 60cm Dual Lumen CT PICC (Ref: PFM2CT6D)
PFMMedical6614 (TM) - ASEPT Procedure Pack (Ref M7040)
Merit1383 (SN, NT) - K13 Label Kit
PFMMedical6614 (TM) - Jet-Vac
Protech3048 (TM) - Shadow
Merit1383 (TM) - Input SSV
Merit1383 (TM) - Split Sheath Introducer Kit wih Valve, et al.
PFMMedical6614 (TM) - 5.5F x 5cm Micro Introducer Kit (Ref M550540)
PFMMedical6614 (TM) - 5.5F x 7cm Micro Introducer Kit (Ref M550740)
PFMMedical6614 (TM) - 4.5F x 5cm Micro Introducer Kit (Ref M450540)
PFMMedical6614 (TM) - 3.5F x 5cm Micro Introducer Kit (Ref M350540)
PFMMedical6614 (TM) - 6.5F x 7cm Micro Introducer Kit (Ref M650740)
PFMMedical6614 (TM) - 3.5F x 7cm Micro Introducer Kit (Ref M350740)
PFMMedical6614 (TM) - 4.5F x 7cm Micro Introducer Kit (Ref M450740)
PFMMedical6614 (TM) - 6.5F x 5cm Micro Introducer Kit (Ref M650540)
Zenflow34605 (TM) - Zenflow Spring Scope
PFMMedical6614 (TM) - NuCath
Auris9616 (TM) - Monarch Platform
Avanos2508 (TM) - ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
Protech3048 (TM) - Suture Sleeve
Protech3048 (TM) - IS4/DF4 Connector Sleeve
Merit1383 (NT,SN,TM) - TruCut 18Ga
Merit1383 (TM) - Aspira Pleural Drainage System
Merit1383 (TM) - Performa Diagnostic Intravascular Catheter
VerathonMedical5877 (TM) - GlideScope BFlex 3.8 Single-Use Bronchoscope System
VerathonMedical5877 (TM) - GlideScope BFlex 2 Slim 3.8 Single-Use Bronchoscope
SurgicalSpecialties6945 (TM) - Stainless steel Sutures
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
Merit1383 (TM) - Merit PAK
Merit1383 (TM) - Impress Angiographic Catheter
Merit1383 (TM) - Worley
Merit1383 (SN) - SafeGuard Focus Compression
Protech3048 (TM) - Valor
Protech3048 (TM) - Lightning
Protech3048 (TM) - Hornet
Protech3048 (TM) - Super Hornet
Protech3048 (TM) - Paratrooper Plantar Plate Repair System
PFMMedical6614 (TM) - VETA Peritoneal Dialysis Introducer Kit (Ref M7230)
Zenflow34605 (TM) - Zenflow Spring Implant Retrieval Device
PFMMedical6614 (TM) - ASEPT Pleural Drainage System (Ref M7001)
PFMMedical6614 (TM) - ASEPT Pleural Catheter Kit (Ref 622289)
PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref 622288)
PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref 622286)
Carefusion5709 (TM) - Alaris Extension Set-
Merit1383 (TM) - Miser Contrast Management System
Avanos2508 (TM) - HOMEPUMP ECLIPSE*
Avanos2508 (TM) - ON-Q* Pump
Avanos2508 (TM) - ON-Q Pain Relief System with Bolus
PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter, Straight, Double Cuff (Ref M7100)
PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter (Ref M7150)
PFMMedical6614 (TM) - VETA Peritoneal Catheter Kit with Curled Catheter (Ref M7225)
PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter, Curled, Double Cuff (Ref M7200)
Protech3048 (TM) - Vampiro
MPS34520 (TM) - 19B, 19CHTP, 19MMTP, 19MTP, 19TP, 900490,900590
AccessSci5463 (TM) -POWERWAND XL 4Fr X 10cm, Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND 5Fr x 10cm Safety Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND XL 4Fr X 8cm, Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - Pouch, PW XL, 4FR, 10CM, CE
AccessSci5463 (TM) - POWERWAND XL 5Fr x 8cm Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND AL-REC 4Fr x 6cm, Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND XL, 4Fr x 8cm Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND 4Fr X 10cm, Safety Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND 5Fr x 8cm Safety Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND XL 5Fr X 10cm, Introducer with Extended Dwell Catheter w Bifurcated Extension Set
AccessSci5463 (TM) - POWERWAND XL 5Fr x 8cm Extended Dwell Catherter
AccessSci5463 (TM) - POWERWAND 4FRr x 8cm, Safety Introducer with Extended Dwell Catheter
AccessSci5463 (TM) - POWERWAND XL 5Fr x 10cm, Introducer with Extended Dwell Catheter
Protech3048 (TM) - Awl
Merit1383 (TM) - Universal Coaxial Needles
Irras9981 (TM) - Hummingbird Quad
Irras9981 (TM) - Hummingbird Solo
Zeiss34518 (TM) - Z Cartridge IOL Delivery System
SurgicalSpecialties6945 (TM) - Barbed Mono Sutures
PFMMedical6614 (TM) - ASEPT Peritoneal Catheter Kit (Ref 622284)
PFMMedical6614 (TM) - ASEPT Peritoneal Drainage System (Ref M7008)
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
Design2052 (NR) - CTS Relief Kit
Martech9038 (TM) - NON CORING HUBER NEEDLE
ReflowMed7417 (TM) - SINC Support Catheter
SurgicalSpecialties6945 (TM) - PTFE Sutures
Merit1383 (TM) - Merit Pressure Monitoring Tubing
Merit1383 (TM)- Merit High Pressure Tubing
Medeologix14372 (TM) - Drainage Collection System (DCS 010)
PFMMedical6614 (TM) - Jet-Vac Drainage Line (Ref M7099)
PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref M7004)
PFMMedical6614 (TM) - Jet-Vac Large Bore Drainage Line Set (Ref M7098)
PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref M7005)
PFMMedical6614 (TM) - Jet-Vac Drainage Line Extension (Ref M7097)
PFMMedical6614 (TM) - ASEPT Power Flush Adaptor
Ursel11054 (MN) - Posi-Stick Introducer Set
Prava (LSRTC) - UGARing
Merit1383 (TM) - Prelude SNAP 165 Valved Splittable Sheath Introducer
Carefusion5709 (TM) - MALE/FEM LUER-LOCK CAPS
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
Channel8222 (TM) - Cerene Cryotherapy Device
MPS34520 (TM) - 900790
MPS34520 (TM) - 17TWV
Irras9981 (TM) - IRRAflow Drainage Collection System
VerathonMedical5877 (TM) - GlideScope BFlex 2.8 Sinlge-Use Bronchoscope System
VerathonMedical5877 (TM) - GlideScope BFlex 2 Ultraslim 2.8 Single-Use Bronchoscope
VerathonMedical5877 (TM) - GlideScope BFlex 2.8 Single-Use Bronchoscope System
Protech3048 (TM) - Stealth
Protech3048 (TM) - Mini Stealth
Avanos2508 (TM) - SOAKER CATHETER
StrykerSustainability (TM) - Reprocessed Prevalon Mobile Air Transfer System (MATS)
StrykerSustainability (TM) - Reprocessed HoverMatt
Merit1383 (TM) - BIG60
Merit1383 (TM) -Basix Compak Inflation Device
Merit1383 (TM) - BIG60 ALPHA Inlfation Device
Femasys4487 (SP) - VariLock Balloon Inflation Syringe
Carefusion (NT,TM) - set, administration, intravascular
SurgicalSpecialties6945 (TM) - PPN Sutures
Syntech3797 (TM) - Syntech International, Inc.
Flexline Anesthesia Cart
Starsys Anesthesia Cart
TerumoMed3380 (PL,NR) - Manan GWI Guide Wire Introducer
PFMMedical6614 (TM) - VETA Peritoneal Dialysis Stylet (Ref M8002)
Protech3048 (TM) - Mond RVOT Stylet
Protech3048 (TM) - Flip Button Suture Anchor
Merit1383 (TM) - Prelude SNAP Splittable Sheath Introducer
Merit1383 (TM) - superDimension Marker Delivery Kit
Merit1383 (TM) - Aspira Peritoneal
Protech3048 (TM) - Post Op Nasal Airway System
TerumoMed3380 (NR) - MedAmicus Coaxial Introducer
SurgicalSpecialties6945 (TM) - PDO Sutures
Innova11059 (TM) - Laguna Clot Retriever System
Innova11059 (TM) - Malibu Aspiration Catheter System
SurgicalSpecialties6945 (TM) - Monoderm Sutures
Merit1383 (TM) - Worley Slitter
Merit1383 (TM) - Transavalvular Insertion tool (TVI)
Merit1383 (TM) - Contamination Sleeve
Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX
Protech3048 (TM) - PHANTOM XL INSULATED DILATORS
VerathonMedical5877 (WT) - GlideScope Ranger Single Use
VerathonMedical5877 (WT) - GlideScope AVL Single Use
VerathonMedical5877 (WT) - GlideScope GVL Single Use
Avanos2508 (TM) - ON-Q*
Avanos2508 (TM) - ON-Q CATHETER, ON-Q ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
Avanos2508 (TM) - ON-Q* Antimicrobial Expansion Kits with SILVERSOAKER* Catheter
Avanos2508 (TM) - ON-Q* ANTIMICROBIAL EXPANSION-Q KITS WITH SILVERSOAKER* ANTIMICROBIAL CATHETER AND NRFit" CONNECTOR
MPS34520 (TM) - 2 PHARM-6
MPS34520 (TM) - 18B
Protech3048 (TM) - Vasoband
Protech3048 (TM) - Thunderbolt
Merit1383 (TM) - ReSolve Locking Drainage Catheter
AmericanCatheter5917 (SP) - American Catheter
Merit1383 (TM) - Cen-Step Centesis Catheter
Avanos2508 (TM) - ON-Q* Tunneler Introducer Sheaths
Avanos2508 (TM) - ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller
Avanos2508 (TM) - ON-Q Tunnelers and Sheaths
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Device in the United States for Export Only