Flexicare Medical Ltd.

FDA Regulatory Profile

Summary

Total Recalls
5 (1 Class I)
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0497-2021Class IProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990September 22, 2020
Z-0801-2020Class IIBriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile November 27, 2019
Z-0804-2020Class IIBriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, RENovember 27, 2019
Z-0802-2020Class IIBriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, SteriNovember 27, 2019
Z-0803-2020Class IIBriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, November 27, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K150900Flexicare Heated Wire Breathing SystemsMay 15, 2015
K140473DUALGUARDApril 10, 2014
K140113O2 NASAL CANNULA WITH CO2 MONITORINGMarch 6, 2014
K132619CLASSIC INTERMITTENT CATHETEROctober 11, 2013
K092218FLEXICARE BREATHING FILTERSOctober 6, 2009
K091591FLEXICARE MEDICAL ENDOTRACHEAL TUBESJune 17, 2009
K951652VENTIMASK MK IVApril 27, 1995