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Flexicare Medical Limited.

8 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
FL-10000U Respiratory Humidifier (K251448)Flexicare Medical Limited.2026-01-16
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) (K250243)Flexicare Medical Limited.2025-05-20
SINGLE USE MANOMETER (K201666)Flexicare Medical Limited.2020-11-13
HepaShield Bacterial Viral Breathing System Filter (K191909)Flexicare Medical Limited.2020-03-23
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 (K181583)Flexicare Medical Limited.2018-12-07
ThermoShield HME Filter (K163300)Flexicare Medical Limited.2017-03-22
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE (K161314)Flexicare Medical Limited.2016-07-06
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (K160540)Flexicare Medical Limited.2016-06-23

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Every clearance here is in the API, with alerts when new ones post.