Nitinol Devices and Components, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 12 (12 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1818-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1820-2014 | Class I | HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1823-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1817-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1813-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1821-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1815-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1816-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guide | May 28, 2014 |
| Z-1814-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1822-2014 | Class I | HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufact | May 28, 2014 |
| Z-1819-2014 | Class I | HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |
| Z-1812-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, | May 28, 2014 |