FDA Registration
Active
🇺🇸 United States
Isomedix Operations Inc.
Reg #: 2246552
·
FEI: 2246552
·
Expires 2026
Products
189
Proprietary Names
281
Establishment Types
2
Classifications
189
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Registration Details
- Registration Name
- Isomedix Operations Inc.
- Registration Number
- 2246552
- FEI Number
- 2246552
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3459 SOUTH CLINTON AVE.
- City
- S Plainfield
- State
- NJ
- ZIP
- 07080
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 9072619
- Address
- 5960 Heisley Road, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2012-11-05 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-11-05 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2023-08-23 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2023-08-23 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2023-08-23 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2023-08-23 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-03-10 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-09-30 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2012-11-05 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2023-07-07 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2023-07-07 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2018-02-20 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2018-02-20 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2020-01-09 |
| Gastric Irrigation And Aspiration Kit | PRT | Class 2 | Gastroenterology, Urology | No | 2020-01-09 |
| Endoscopic Storage Cover | OCU | Class 2 | Gastroenterology, Urology | No | 2020-02-08 |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | Class 2 | Neurology | No | 2024-04-12 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2023-05-30 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2018-08-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2012-11-06 |
| Pump, Infusion, Insulin Bolus | OPP | Class 2 | General Hospital | No | 2024-09-18 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2023-04-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2012-12-17 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2012-12-27 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-09-04 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2012-11-05 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2012-12-20 |
| Keratome, Battery-Powered | HMY | Class 1 | Ophthalmic | No | 2015-05-04 |
| Sealant, Microbial | NZP | Class 2 | General, Plastic Surgery | No | 2018-02-08 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2017-05-11 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2015-05-04 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2012-11-05 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2023-06-21 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2015-06-04 |
| Optical Coherence Tomography, Intravascular Catheter | ORD | Class 2 | Cardiovascular | No | 2015-06-04 |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2024-09-05 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2020-03-09 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2020-12-04 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2014-11-13 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2022-02-08 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2022-01-05 |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | Class 2 | General, Plastic Surgery | No | 2018-02-08 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2012-12-17 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2015-05-08 |
| Cap, Cervical | HDR | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2024-01-10 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-12-28 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2012-11-05 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2015-03-03 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2015-03-03 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2022-01-05 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2014-06-16 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-02-19 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2025-02-19 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2025-02-19 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2025-02-19 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2020-04-30 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2022-05-27 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2024-09-18 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2022-11-01 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2022-11-01 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2012-11-05 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2014-11-04 |
| Extractor, Vacuum, Fetal | HDB | Class 2 | Obstetrics/Gynecology | No | 2014-04-08 |
| System, Catheter Control, Steerable | DXX | Class 2 | Cardiovascular | No | 2022-10-19 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2024-01-23 |
| Electrocautery, Gynecologic (And Accessories) | HGI | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Microtools, Assisted Reproduction (Pipettes) | MQH | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-11-27 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2023-06-15 |
| Device, Hemostasis, Vascular | MGB | Class 3 | Unknown | No | 2025-12-02 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2015-04-07 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2020-12-14 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2023-06-02 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2026-03-19 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2018-08-31 |
| Curette, Suction, Endometrial (And Accessories) | HHK | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2019-09-27 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2020-05-26 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2015-03-02 |
| Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | ODD | Class 2 | Gastroenterology, Urology | No | 2022-01-05 |
| Interoperable Automated Glycemic Controller | QJI | Class 2 | Clinical Chemistry | No | 2024-09-05 |
| Stethoscope, Esophageal, With Electrical Conductors | BZT | Class 2 | Anesthesiology | No | 2023-06-12 |
| Mesh, Surgical, Deployer | ORQ | Class 2 | General, Plastic Surgery | No | 2023-10-25 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2023-10-25 |
| Dislodger, Stone, Flexible | FGO | Class 2 | Gastroenterology, Urology | No | 2018-08-31 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2020-12-04 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2022-11-01 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2012-12-17 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2020-03-10 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2025-05-05 |
| Mechanical Thrombolysis Catheter | QEY | Class 2 | Cardiovascular | No | 2025-05-05 |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | Class 2 | Cardiovascular | No | 2020-12-18 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2023-07-07 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-11-25 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2020-01-23 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-01-23 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2026-02-11 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2023-04-27 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-09-19 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2015-11-10 |
| Brush, Biopsy, Bronchoscope (Non-Rigid) | BTG | Class 2 | Ear, Nose, Throat | No | 2023-04-27 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2020-01-03 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2020-01-03 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2023-06-15 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2023-05-08 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2018-08-31 |
| Cannula, Intrauterine Insemination | MFD | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2017-11-22 |
| Midline Catheter | PND | Class 2 | General Hospital | No | 2017-05-11 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2012-11-05 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2024-04-16 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2018-09-02 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2024-09-05 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2015-11-10 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2020-03-10 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2012-12-20 |
| Pump, Infusion, Implanted, Programmable | LKK | Class 3 | Unknown | No | 2024-10-18 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2026-04-01 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2012-10-26 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2025-01-08 |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2023-05-31 |
| Amniotome | HGE | Class 1 | Obstetrics/Gynecology | No | 2012-12-27 |
| Brush, Endometrial | HFE | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-01-10 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2013-01-08 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2012-11-05 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2018-08-31 |
| Aspirator, Endocervical | HFC | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2012-11-05 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2024-09-04 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 2024-01-23 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2020-12-14 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2023-10-25 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2019-10-12 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2023-01-10 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2012-12-17 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-04-07 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2012-11-05 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2020-10-30 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2018-08-31 |
| Fluid Jet Removal System | PZP | Class 2 | General, Plastic Surgery | No | 2023-12-04 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2012-12-27 |
| Sampler, Endocervical | PCF | Class 2 | Obstetrics/Gynecology | No | 2014-04-08 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2012-12-27 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2012-11-06 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | Class 1 | Obstetrics/Gynecology | No | 2014-04-08 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2014-04-08 |
| Pump, Infusion, Ophthalmic | MRH | Class 2 | General Hospital | No | 2012-11-05 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2024-04-08 |
| Graft, Vascular, Synthetic/Biologic Composite | MAL | Class 2 | Cardiovascular | No | 2020-03-09 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2012-12-17 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2012-12-17 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2012-12-20 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2018-02-20 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2023-05-30 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2012-11-05 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2015-05-04 |
| Transvenous Temporary Phrenic Nerve Stimulator | SDL | Class 3 | Unknown | No | 2025-03-18 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2018-08-31 |
| Aspirator, Endometrial | HFF | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Transilluminator, Ac-Powered | HJM | Class 2 | Ophthalmic | No | 2012-11-05 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2012-12-17 |
| Brush, Biopsy, General & Plastic Surgery | GEE | Class 1 | General, Plastic Surgery | No | 2025-11-25 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2020-11-19 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2020-01-23 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2023-10-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2023-10-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2023-10-18 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2019-04-08 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-11-16 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-12-04 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2020-12-04 |
| Connector, Ureteral Catheter | EYK | Class 1 | Gastroenterology, Urology | No | 2022-01-05 |
| Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision | SFQ | Class 2 | General, Plastic Surgery | No | 2025-12-15 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | HES | Class 2 | Obstetrics/Gynecology | No | 2012-12-17 |
| Hydrogel Spacer | OVB | Class 2 | Radiology | No | 2023-06-15 |
Proprietary Names
Peregrine3901 (PL) - Membrane Scraper
Peregrine3901 (PL) - Tapered Diffusion Illuminator
Peregrine3901 (PL) - Endoilluminator
MicrolineSurgical3881 (PL) - Disposable ReNew Forceps
MicrolineSurgical3881 (PL) - ReNew Forceps
MicrolineSurgical3881 (PL) - Electrosurgical Cautery Probes
MicrolineSurgical3881 (PL) - ReNew Laparoscopic Instruments
Globus4330 (PL) - PROVIDENT
Peregrine3901 (PL) - Powered laser surgical instrument
Navilyst5285 (PL) - Mini Stick ENVI
LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD Singles Pledgeted Striped
LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD 6-Tray
LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD Singles Pledgeted Green
LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD Singles Striped
LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD Singles Pledgeted White
US_Endoscopy4223 (PL) - AquaShield System CO2 FUJIFILM
US_Endoscopy4223 (PL) - AquaShield System CO2
US_Endoscopy4223(PL) - AquaShield System- PENTAX
US_Endoscopy4223 (PL) - AquaShield System- CO2 PENTAX
US_Endoscopy4223 (PL) - Irrigation Kit Standard
US_Endoscopy4223 (PL) - Irrigation Kit CO2 Long
US_Endoscopy4223 (PL) - BioGuard air/water & suction valves-Olympus (4 pc kit)
US_Endoscopy4223 (PL) - BioGuard air/water & suction valves-Olympus (3 pc kit)
US_Endoscopy4223 (PL) - Irrigation Kit CO2 Short
US_Endoscopy4223 (PL) - Endoscopic Tip Protector
US_Endoscopy4223 (PL) - Articulator injection needle - enteroscope
US_Endoscopy4223 (PL) - Carr-Locke injection needle
US_Endoscopy4223 (PL) - Articulator injection needle
Peregrine3901 (PL) - Instrument, manual, Surgical, General Use
Hobbs3950 (PL) - Microbiology Brush
Peregrine3901 (PL) - Keratome, battery-powered
Navilyst5285 (PL) - BioFlo Midline
Peregrine3901 (PL) - Photocagulator and accessories
Insulet5490 (NR) - Omnipod 5 Automated Insulin Delivery System
LSISol6612 (PL) - PNEUMOSTOP PLUS Device
LSISol6612 (PL) - PNEUMOSTOP Device
Zimmer (PL) - ZIMMER SEGMENTAL SYSTEM
B&L1665 (PL) - PMMA Anterior Chamber Intraocular Lens
TerumoMed3380 (PL) - Radifocus Introducer II
TerumoMed3380 (PL) - Radifocus Introducer II with R/O Marker
L&Z7835 (PL) - CATHTONGTM II PICC Catheter
TerumoMed3380 (PL) - Glidesheath Slender
LSISol6612 (PL) - RD QUICK LOAD SUTURE 2-0 MONOGLIDE
LSISol6612 (PL) - RD QUICK LOAD SUTURE 2-0 STRONGSORB
LSISol6612 (PL) - RD QUICK LOAD SUTURE 0 Polyester
LSISol6612 (PL) - RD QUICK LOAD SUTURE 0 MONOGLIDE
US_Endoscopy4223 (PL) - BioShield Biopsy Valve
LSISol6612 (PL) - FS-35 FS DEVICES
LSISol6612 (PL) - Combo Box of 6 FORNISEE Devices - 2 each of FS-30, FS-35, FS-40
LSISol6612 (PL) - FS-40 FS DEVICES
LSISol6612 (PL) - FS-30 FS DEVICES
DORC10527 (PL) - Phacoemulsification / Vitrectomy System
DORC10527 (PL) - Vitrectomy System
DORC10527 (PL) - Phacoemulsification / Vitrectomy System / Ophthalmic Laser
MicrolineSurgical (PL) - ReNew Disposable Scissor Tip
MicrolineSurgical3881 (PL) - ReNew Metzenbaum Scissor Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Microscissor Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Mini Endocut Scissor Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Endocut Scissor Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Hook Scissor Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Delicate Metzenbaum Scissor Tip, Disposable
Navilyst5285 (PL) - Xcela
US_Endoscopy4223 (PL) - Padlock Clip Defect Closure System
US_Endoscopy4223 (PL) - Padlock Clip Pro-Select Defect Closure System
Zimmer (PL) - Persona Revision Knee System
Navilyst5285 (PL) - BioFlo
Hobbs3950 (PL) - Looped Retriever
Navilyst5285 (PL) - Mini Stick Max
Cornidus5713 (PL) - System, Catheter Control, Steerable
Zimmer (PL) - ROSA® Knee System
TerumoMed3380 (PL) - Femoseal
JamesAlex4786 (PL) - Mastisol blister Italian version (bilk-packed)
JamesAlex4786 (PL) -Mastisol blister (bulk-packed)
JamesAlex4786 (PL) - Detachol blister UK version
JamesAlex4786 (PL) - Mastisol blister UK version
JamesAlex4786 (PL) - Detachol blister Italian version
JamesAlex4786 (PL) - Detachol blister
US_Endoscopy4223 (PL) - Histolock Resection Device
TerumoMed3380 (PL) - Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal guide
Navilyst5285 (PL) - SmartPort+ and SmartPort Plastic
LSISol6612 (PL) - RD THE RUNNING DEVICE BARIATRIC LENGTH
LSISol6612 (PL) - RD THE RUNNING DEVICE
Zimmer (PL) - ROSA Knee System
US_Endoscopy4223 (PL) - BioShield Biopsy Valve EUS
Insulet5490 (PL) - Omnipod 5 Automated Insulin Delivery System
US_Endoscopy4223 (PL) - Talon Grasping Device
TerumoMed3380 (PL) - MedAmicus Coaxial Introducer
TerumoMed3380 (PL) - Pinnacle R/O II Introducer Kit
US_Endoscopy4223 (PL) - Torrent irrigation scope connector - Pentax
US_Endoscopy4223 (PL) - Torrent irrigation tubing
Peregrine3901 (PL) - Device, irrigation, ocular surgery
Globus4330 (PL) - PROVEN Gen-Flex
Peregrine3901 (PL) - Keratome (Microkeratome) Blade
Viant8257 (PL) - Raphael 25L
NisshaMedical (PL) - Copilot Q
TerumoMed3380 (PL) - Manan GWI Guide Wire Introducer
Hobbs3950 (PL) - Scope Introducer
TriceMedical7859 (PL) - mi-eye 2
MicrolineSurgical3881 (PL) - ReNew Straight Cautery Probe Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew L-Hook Cautery Probe Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Spatula Cautery Probe Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew J-Hook Cautery Probe Tip, Disposable
Thermedx7581 (PL) - Luer Lock Set, Single Lumen
Thermedx7581 (PL) - Urology Set
Thermedx7581 (PL) - Tubing Set - Single Lumen, Inflow with Dual Outflow
TerumoMed3380 (PL) - Pinnacle Introducer Sheath, Radifocus Introducer II
LSISol6612 - LS-5 ePTFE Suture
US_Endoscopy4223 (PL) - Coin Tip Snare
US_Endoscopy4223 (PL) - Lariat Snare
Intera9479 (PL) - Non-Coring (Huber) Needle - Intera 3000 Refill Kit
TerumoMed3380 (PL) - Pinnacle R/O II, Radifocus Introducer II with R/O Marker
US_Endoscopy4223 (PL) - Infinity Cytology Brush
US_Endoscopy4223 (PL) - Histoguide wire-guided forceps
Globus4330 (PL) - Concord Bone Cement
Navilyst5285 (PL) -BioFlo PICC
Hobbs3950 (PL) - Transbronchial Aspiration Needle
Hobbs3950 (PL) - superDimension Aspirating Needle
US_Endoscopy4223 (PL) - BioGuard valves & air/water cleaning adapter kit (00711785)
US_Endoscopy4223 (PL) - BioGuard valves (3-pc) & air/water cleaning adapter kit (00711786)
Insulet5490 (PL) - Omnipod DASH Insulin Management System
Insulet5490 (PL) - OmniPod Insulin Management System
Peregrine3901 (PL) - Cannula, ophthalmic
J&J2483 (GP) - Band-Aid
Intera9479 (PL) - Accessories for Model 3000 Series Implantable Infusion Pump
Hobbs3950 (PL) - Mistifier Spray Catheter Endogator Spray Catheter
Globus4330 (PL) - Kinex
Medivators2752 (PL) - Defendo Fujifilm 700 series valve kits
LSISol6612 (PL) - COR-SUTURE QUICK LOAD - 2-0 Polyester, White, Non-Absorbable
LSISol6612 (PL) - COR-KNOT QUICK LOAD 6-POUCH
LSISol6612 (PL) - C1 Depth Limiter
LSISol6612 (PL) - COR-KNOT QUICK LOAD SINGLES
LSISol6612 (PL) - C1 Device
LSISol6612 (PL) - COR-KNOT MINI COMBO KIT
LSISol6612 (PL) - COR-KNOT MIS COMBO KIT
LSISol6612 (PL) - RD QUICK LOAD SUTURE 2-0 Polypropylene
LSISol6612 (PL) - C1 Device (Straight Shaft)
LSISol6612 (PL) - RD180 10mm THE RUNNING DEVICE
LSISol6612 (PL) - TK Ti-KNOT DEVICE
LSISol6612 (PL) - COR-KNOT MIS DEVICE KIT
LSISol6612 (PL)- RD QUICK LOAD SUTURE 2-0 Polyester
LSISol6612 (PL) - RD180 SP THE RUNNING DEVICE
LSISol6612 (PL)- COR-SUTURE QUICK LOAD - 3-0 Polypropylene, Non-Absorbable
LSISol6612 (PL) - INTRA-KNOT QUICK LOAD
LSISol6612 (PL) - COR-KNOT MINI DEVICE KIT
LSISol6612 (PL) - COR-SUTURE QUICK LOAD - 2-0 Polyester, Green, Non-Absorbable
LSISol6612 (PL) - RD180 5mm THE RUNNING DEVICE
LSISol6612 (PL)- TK QUICK LOAD
StrykerSustainability6623 (SDA) - Electrode Cable
Innovative7777 (SDA) - CABLE, ELECTRODE
L&Z7835 (PL) - CATHTONG I PICC Catheter
Navilyst5285 (PL) - PASV MS KIT
WellsLamont8889 (PL) - Cut Resistant Surgical Glove Liners
Hobbs3950 (PL) - Freeman Pancreatic Flexi-Stent - Straight
Hobbs3950 (PL) - Pusher Catheter
Hobbs3950 (PL) - Freeman Pancreatic Flexi-Stent - Single Pigtail
Hobbs3950 (PL) - Guide Catheter
Globus4330 (PL) - GenFlex2
US_Endoscopy4223 (PL) - Moray micro forceps
TerumoMed3380 (PL) - Pinnacle R/O II HiFlo
MicrolineSurgical3881 (PL) - M/L-10 Clip Cartridge, 19 Clips, Disposable
MicrolineSurgical3881 (PL) - M/L-10 Clip Cartridge, 8 Clips, Disposable
MicrolineSurgical3881 (PL) - M/L-10 Clip Cartridge, 10 Clips, Disposable
MicrolineSurgical3881 (PL) - Clip / Scissor Procedure Kit, M/L-10 Cartridge 19 Clips (1), Endocut Scissor Tip (1)
US_Endoscopy4223 (PL) - Articulator Injection Needle; Carr-Locke Injection Needle
DORC10527 (PL) - device, irrigation, ocular surgery
US_Endoscopy4223 (PL) - Roth Net Retrieval Devices- Foreign Body Universal
US_Endoscopy4223 (PL) - Roth Net Retrieval Devices- Foreign Body Standard
US_Endoscopy4223 (PL) - Roth Net Retrieval Devices-Foreign Body Maxi
Navilyst5285 (PL) - Exodus Nuance
Navilyst5285 (PL) - Exodus Believe
Navilyst5285 (PL) - Exodus Array
US_Endoscopy4223 (PL) - Torrent Irrigation Tubing
LSISol6612 (PL) - Aortic Root Retractor, Medium
LSISol6612 (PL) - SEW-EASY Cassette Singles, 5mm
LSISol6612 (PL) - 3D MINI ACESS PORTAL
LSISol6612 (PL) - RAM PACK
LSISol6612 (PL) - SEW-EASY COMBO Kit, 5mm
LSISol6612 (PL) - Aortic Root Retractor, Large
LSISol6612 (PL) - MINI-RUMEL
LSISol6612 (PL) - SEW-EASY M Device
LSISol6612 (PL) - RAM Device
LSISol6612(PL) - RAM RING
LSISol6612 (PL) - SEW-EASY Device Kit
LSISol6612 (PL) - Aortic Root Retractor, Small
LSISol6612 (PL) - SEW-EASY SNARE
LSISol6612 (PL) - SEW-EASY Cassettes
LSISol6612 (PL) - SEW-EASY Device Kit, 5mm
LSISol6612(PL) - SEW EASY Combo Kit
LSISol6612(PL) - RAM Device 5mm
Peregrine3901 (PL) - Catheter, continuous flush
Conformis6082 (PL) - Kinos
Globus4330 (PL) - BIOLOX DELTA
Peregrine3901 (PL) - Laser, ophthalmic,
Peregrine3901 (PL) - Aspirating Laser Probe, Ophthalmic
DORC10527 (PL) - endoilluminator
TerumoMed3380 (PL) - R2P Destination Slender Guiding Sheath
US_Endoscopy4223 (PL) - Infinity ERCP sampling device
Lacey2530 (PL) - BES NIM NAV PAK NEEDLE TROCAR
TerumoMed3380 (PL) - TR Band; TR BAND Radial Compression Device
Hobbs3950 (PL) - Ureteral Double Pigtail Stent
Hobbs3950 (PL) - Biliary Pigtail Stents
US_Endoscopy4223 (PL) - AquaShield system
Peregrine3901 (PL) - Shilded Diffusion Illuminator
US_Endoscopy4223 (PL) - Exacto cold snare
US_Endoscopy4223 (PL) - iSnare system-Lariat Snare
US_Endoscopy4223 (PL) - Traxtion hexagonal snare
US_Endoscopy4223 (PL) - Rotator - snare - mini-oval
US_Endoscopy4223 (PL) - Short Throw - snare - enteroscope
US_Endoscopy4223 (PL) - Short Throw - snare - mini-oval
US_Endoscopy4223 (PL) - Rotator - snare - oval
US_Endoscopy4223 (PL) - Short Throw - snare - oval
L&Z7835 (PL) - CATHTONGTM III Tapered PICC Catheter
TerumoMed3380 (PL) - Glidesheath
Adhezion5351 (PL) - Surgiseal Stylus
Navilyst5285 (PL) - Vaxcel Mini Stick
MicrolineSurgical3881 (PL) - ReNew Grabber Grasper Tip, Disposable
MicrolineSurgical (PL) - ReNew Disposable Forceps Tip
MicrolineSurgical3881 (PL) -ReNew Long Fenestrated Grasper Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Modified Babcock Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Super Atraumatic Grabber Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Babcock Grasper Tip, 5mm, Disposable
MicrolineSurgical3881 (PL) -ReNew Modified Raptor Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Micro Fenestrated Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Traditional Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Cobra Tooth Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Fenestrated Grasper Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Hunter Grasper Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Babcock Grasper Tip, 10mm, Disposable
MicrolineSurgical3881 (PL) -ReNew Allis Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Traditional Maryland Dissector Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Lapclinch Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Modified Traditional Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Super Atraumatic Short Grasper Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Dolphin Nose Dissector Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Right Angle Dissector Tip, 10mm, Disposable
MicrolineSurgical3881 (PL) - ReNew Super Atraumatic Fenestrated Grasper Tip, Disposable
MicrolineSurgical3881 (PL) -ReNew Modified Maryland Dissector Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Super Atraumatic Modified Grasper Tip, Disposable
MicrolineSurgical3881 (PL) - ReNew Right Angle Dissector Tip, 5mm, Disposable
MicrolineSurgical3881 (PL) - ReNew Forceps Micro Tip, Disposable
US_Endoscopy4223 (PL) - Raptor grasping device
US_Endoscopy4223 (PL) - Raptor grasping device - mini
LeMaitre3746 (PL) - Albograft Vascular Graft
WellsLamont8889 (PL) - Cut-Tec or Wells Lamont Polyester/Wire Cut Resistant Glove Liner Wells_Tec, Sceptert
US_Endoscopy4223 (PL) - BioGuard Air/Water and Suction valves (00711780) (EN-SD)
DORC10527 (PL) - Instrument, vitreous aspiration and cutting, AC-powered
DORC10527 (PL) - hacoemulsification / Vitrectomy System / Ophthalmic Laser
DORC10527 (PL) - unit, phacofragmentation
DORC10527 (PL) - Phacoemulsification/Vitrectomy System
Peregrine3901 (PL) - Laser, ophthalmic
Visu-Loc 5mm Clip Applier
US_Endoscopy4223 (PL) - Polypectomy Snares
Peregrine3901 (PL) - Keratome, ac-powered
US_Endoscopy4223 (PL) - Reveal Distal Attachment Cap
US_Endoscopy4223 (PL) - Oracle EUS latex balloon-Olympus linear
US_Endoscopy4223 (PL) - Oracle EUS latex balloon-Olympus radial
Insulet5490 (NR) - Omnipod GO Insulin Delivery Device
Hydrofera2363 (PL) - Hydrofera Blue Ready Border
Peregrine3901 (PL) - Illuminating Laser Probe, Ophthalmic
Navilyst5285 (PL) - Solero
Johnson & Johnson (GP) - Band-Aid
Insulet5490 (PL) - PodPals Adhesive Overlay
Insulet5490 (PL) - Adhesive Overlay
B&L1665 (PL) - Softport Posterior Chamber Intraocular Lens
TriceMedical7859 (PL) - mi-eye 3
US_Endoscopy4223 (PL) - Roth Net - foreign body standard
US_Endoscopy4223 (PL) - Roth Net - foreign body maxi
US_Endoscopy4223 (PL) - Roth Net Platinum - universal
US_Endoscopy4223 (PL) - Roth Net retriever select
US_Endoscopy4223 (PL) - Roth Net retriever - mini polyp
US_Endoscopy4223 (PL) - Roth Net Platinum - polyp
US_Endoscopy4223 (PL) - Roth Net retriever - 360
US_Endoscopy4223 (PL) - Roth Net - foreign body mini
US_Endoscopy4223 (PL) - Roth Net Retrieval Devices- Pediatric
US_Endoscopy4223 (PL) - UroSeal adjustable endoscopic valve (00913410) (EN-CFE)
Intera9479 (PL) - Non-Coring (Huber) Needle - Intera Non-Coring (Huber) Refill Needles
Intera9479 (PL) - Non-Coring (Huber) Needle - Intera Non-Coring (Huber) Special Bolus Needles
Intera9479 (PL) -Non-Coring (Huber) Needle - Intera OR Prep Kit
Conformis6082 (PL) - iTotal Identity Cruciate Retaining Knee Replacement System
BioMed3889 (PL) - Rylon-1
J&J2483 (GP) - Band-Aid; Johnson & Johnson Red Cross
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Device in the United States for Export Only