Medical Device Manufacturer · GB , Mountain Ash

Flexicare Medical Limited. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2016

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

FDA 510(k) Regulatory Record - Flexicare Medical Limited. Anesthesiology ✕

6 devices

1-6 of 6

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 Dec 07, 2018

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use...

Anesthesiology · 175d

Cleared Jul 06, 2016

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

Anesthesiology · 56d

Cleared Jun 23, 2016

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

Anesthesiology · 118d