Table 5:
FDA approved WDB devices, sensor and detection kit used for diagnosis beside cancer treatment137 (Table reproduced from [137])
| Device name | Application area |
|---|---|
| CentriMag Circulatory Support System - P170038 | Blood Pump |
| FoundationOne®CDx - P170019/S006 | Laboratory Test |
| LIAISON QuantiFERON-TB Gold Plus, LIAISON Control QuantiFERON-TB Gold Plus, LIAISON QuantiFERON Software - P180047 | Laboratory Test |
| Tula® System - P190016 | Ear Tubes |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter - P190008 | Balloon Catheter |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear – P180035 | Contact Lenses |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control – P180046 | Urinary Retention |
| Myriad myChoice CDx - P190014 | Laboratory Test |
| LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab - P190011 | Laboratory Test |
| iDESIGN® Refractive Studio and STAR S4 IR® Excimer Laser Systems – P930016/S057 | Laser Vision Correction |
| Axonics Sacral Neuromodulation (SNM) System - P190006 | Incontinence |
| Alcon Laboratories, Inc. AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60) - P040020/S087 | Intraocular Lens |
| Minimally Invasive Deformity Correction (MID-C) System - H170001 | Spine |
| BAROSTIM NEO System - P180050 | Heart Failure |
| The Tether™ - Vertebral Body Tethering System - H190005 | Spine |
| Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058 | Heart Valve |
| Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S085 | Heart Valve |
| PD-L1 IHC 22C3 pharmDx - P150013/S016 | Laboratory Test |
| MED-EL Cochlear Implant System - P000025/S104 | Cochlear Implant |
| Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033 | Heart Valve |
| PD-L1 IHC 22C3 pharmDx - P150013/S014 | Laboratory Test |
| HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A) - P160029 | Defibrillator |
| Eversense Continuous Glucose Monitoring System - P160048/S006 | Glucose Monitor |
| Hintermann Series H3™ Total Ankle Replacement System - P160036 | Joint Replacement |
| TransMedics OCS Lung System - P160013/S002 | Lung Donor |
| Neuroform Atlas® Stent System - P180031 | Stent |
| VICI VENOUS STENT® System - P180013 | Stent |
| Tack Endovascular System® (6F) - P180034 | Vascular |
| XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014 | Perfusion System |
| LOTUS Edge™ Valve System - P180029 | Heart Valve |
| TransPyloric Shuttle/TransPyloric Shuttle Delivery Device - P180024 | Weight Loss |
| TherOx DownStream System - P170027 | Oxygen Therapy |
| Cerene Cryotherapy Device - P180032 | Menstrual Bleeding |
| TRILURON™ - P180040 | Osteoarthritis |
| OPTIMIZER Smart System - P180036 | Cardiovascular |
| MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S028 | Vascular |
| VENOVO Venous Stent System - P180037 | Stent |
| COVERA™ Vascular Covered Stent - P170042/S002 | Stent |
| VENTANA PD-L1 (SP142) Assay - P160002/S009 | Hernia |
| M6-C™ Artificial Cervical Disc - P170036 | Spine |
| MANTA Vascular Closure Device - P180025 | Vascular |