FDA Device Registration & Listing · Phoenix, AZ, US · Registration 2090040
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | Class 2 | 870.1200 | 2023-08-01 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2023-08-01 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2013-04-15 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2010-02-05 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2021-04-28 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-04-28 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2010-12-06 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | Class 2 | 870.1200 | 2019-05-10 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2010-02-05 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2016-04-13 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2016-04-13 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Orthopedic | Class 2 | 888.3030 | 2016-04-13 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2010-02-05 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2010-02-05 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | Class 2 | 870.2900 | 2010-02-05 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2010-02-05 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| FWP | Prosthesis, Chin, Internal | General, Plastic Surgery | Class 2 | 878.3550 | 2019-08-21 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2021-04-29 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2010-02-05 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2010-02-05 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | Class 2 | 870.1200 | 2010-02-05 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2012-11-12 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | Orthopedic | Class 2 | 888.3770 | 2021-04-23 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2021-04-28 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2021-04-28 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-04-28 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2010-02-05 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2010-02-05 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2010-02-05 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2021-04-26 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-04-28 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2021-04-28 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2010-07-23 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2021-04-26 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2010-02-05 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | Class 2 | 870.2900 | 2010-02-05 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2020-05-14 |
| FMR | Device, Transfer, Patient, Manual | General Hospital | Class 1 | 880.6785 | 2008-12-30 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2011-10-18 |
| KWF | Prosthesis, Finger, Polymer | Orthopedic | Class 2 | 888.3230 | 2021-05-03 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Orthopedic | Class 2 | 888.3030 | 2010-02-05 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2010-02-05 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2010-02-05 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | Class 2 | 870.2900 | 2010-02-05 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | Class 2 | 870.1200 | 2010-02-05 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-04-28 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2021-04-22 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3003897776 | BIOMIMETIC THERAPEUTICS,LLC | FRANKLIN, TN, US |
| 3040801290 | Inari Medical, Costa Rica S.A. | Grecia Alajuela, CR |
| 2031049 | TMJ Solutions, LLC | San Buenaventura, CA, US |
| 3016573902 | Ortho-Space Ltd. | Caesarea Haifa, IL |
| 3010411911 | POM Medical, LLC | Moorpark, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K232130 | Surgical Instrument Services and Savings, Inc. | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | 2023-12-15 |
| K230934 | ABBOTT MEDICAL | ViewFlex Eco Reprocessed ICE Catheter | 2023-05-03 |
| K251211 | ABBOTT MEDICAL | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | 2025-05-23 |
| K251231 | ABBOTT MEDICAL | ViewFlex X ICE Catheter, Sensor Enabled | 2025-05-20 |
| K101883 | St Jude Medical | 6F ENGAGE/ENGAGE TR INTRODUCER | 2010-09-07 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-2016 | Biosense Webster, Inc. | 2 | SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. |
| Z-0783-2020 | Abbott Medical | 2 | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 |
| Z-0789-2020 | Abbott Medical | 2 | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential. |
| Z-0014-2014 | Synthes USA HQ, Inc. | 2 | Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. |
| Z-0026-2013 | Orthohelix Surgical Designs Inc | 2 | OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2182269 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Minnetonka, MN, US |
| 3011276773 | STERILMED, INC. | Plymouth, MN, US |
| 2032112 | Isomedix Operations Inc. | SAN DIEGO, CA, US |
| 3011024991 | Nypro Inc (Maple Grove) | Maple Grove, MN, US |
| 3005467144 | NORTHEAST SCIENTIFIC, INC. | Waterbury, CT, US |
2090040 when referencing this establishment in official correspondence.