AMD Medicom Inc.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1146-2024Class IIHENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)December 21, 2023
Z-1148-2024Class IIPATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)December 21, 2023
Z-1147-2024Class IIHENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)December 21, 2023
Z-0494-2020Class IIMEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040October 11, 2019
Z-0495-2020Class IIMEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042October 11, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K190306AMD Ritmed AssureWear VersaGownJanuary 17, 2020
K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask SofSeptember 17, 2019