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Flexicare Medical Limited.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories6
Latest Approval2026-01-16
TypeNumberDevice NameCodeDate
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
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