Childrens Medical Ventures
FDA Regulatory Profile
Childrens Medical Ventures appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 1 510(k) clearance, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2192-2014, Class I) was initiated on May 28, 2014. Its most recent 510(k) clearance was granted on March 30, 2011.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2192-2014 | Class I | Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and crad | May 28, 2014 |
| Z-1789-2014 | Class II | Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor. | April 29, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K103410 | NEOPAP SYSTEM | March 30, 2011 |