CushionCast Moldable Cushions— 510(k) K162265
Substantially EquivalentIzi Medical Products, LLC
FDA 510(k) clearance K162265 for CushionCast Moldable Cushions, Substantially Equivalent on 2016-11-15. Applicant: Izi Medical Products, LLC.
Clearance details
- Applicant
- Izi Medical Products, LLC
- Product code
- Code IYE
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Owings Mills, MD, US
Adverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.