Flexicare Medical Limited.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251448 | FL-10000U Respiratory Humidifier | January 16, 2026 |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Vi | May 20, 2025 |
| K201666 | SINGLE USE MANOMETER | November 13, 2020 |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | March 23, 2020 |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Press | December 7, 2018 |
| K163300 | ThermoShield HME Filter | March 22, 2017 |
| K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE | July 6, 2016 |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | June 23, 2016 |