Flexicare Medical Limited. is one of 195 FDA 510(k) medical device manufacturers from United Kingdom in the dataset, ranked by real submission volume.
Flexicare Medical Limited. - FDA 510(k) Cleared Devices
Recent clearances: FL-10000U Respiratory Humidifier, ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U), SINGLE USE MANOMETER
8
Total
8
Cleared
0
Denied
Flexicare Medical Limited. has 8 FDA 510(k) cleared medical devices. Based in Mountain Ash, GB.
Latest FDA clearance: Jan 2026. Active since 2016. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Flexicare Medical Limited. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Flexicare Medical Limited.
8 devices
Cleared
Jan 16, 2026
FL-10000U Respiratory Humidifier
Anesthesiology
252d
Cleared
May 20, 2025
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U)
Anesthesiology
113d
Cleared
Nov 13, 2020
SINGLE USE MANOMETER
Anesthesiology
147d
Cleared
Mar 23, 2020
HepaShield Bacterial Viral Breathing System Filter
General Hospital
250d
Cleared
Dec 07, 2018
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use...
Anesthesiology
175d
Cleared
Mar 22, 2017
ThermoShield HME Filter
General Hospital
120d
Cleared
Jul 06, 2016
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
Anesthesiology
56d
Cleared
Jun 23, 2016
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
Anesthesiology
118d