Flexicare Medical Limited.
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories6
Latest FDA decision2026-01-16
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251448 | FL-10000U Respiratory Humidifier | BTT | 2026-01-16 | View |
| 510(k) | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | BTR | 2025-05-20 | View |
| 510(k) | K201666 | SINGLE USE MANOMETER | CAP | 2020-11-13 | View |
| 510(k) | K191909 | HepaShield Bacterial Viral Breathing System Filter | CAH | 2020-03-23 | View |
| 510(k) | K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 | BTM | 2018-12-07 | View |
| 510(k) | K163300 | ThermoShield HME Filter | CAH | 2017-03-22 | View |
| 510(k) | K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE | BTT | 2016-07-06 | View |
| 510(k) | K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | BZE | 2016-06-23 | View |
No matching devices.