Stradis Medical, LLC dba Stradis Healthcare

FDA Regulatory Profile

Summary

Total Recalls
93
510(k) Clearances
0
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0492-2023Class IISurgical room, SURGICAL PACK, Item No.40996WLS, oral surgery trayNovember 2, 2022
Z-0505-2023Class IIHENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482November 2, 2022
Z-0519-2023Class IIHENRY SCHEIN, PACEMAKER PACK IItem No.570-2793November 2, 2022
Z-0504-2023Class IIHENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery trayNovember 2, 2022
Z-0524-2023Class IIHENRY SCHEIN, Knee Pack, Item No.570-2908,November 2, 2022
Z-0525-2023Class IIHENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930November 2, 2022
Z-0483-2023Class IISTRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSSNovember 2, 2022
Z-0536-2023Class IISTRADIS HEALTHCARE, Lipo, Item No.681-254,November 2, 2022
Z-0527-2023Class IIHENRY SCHEIN, Amnio Tray, Item No.570-3059,November 2, 2022
Z-0490-2023Class IISTRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery trayNovember 2, 2022
Z-0501-2023Class IISTRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery trayNovember 2, 2022
Z-0545-2023Class IISTRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,November 2, 2022
Z-0544-2023Class IISTRADIS HEALTHCARE, Angioplasty, Item No.682-1937,November 2, 2022
Z-0523-2023Class IIHENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,November 2, 2022
Z-0531-2023Class IIHENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,November 2, 2022
Z-0486-2023Class IISTRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery trayNovember 2, 2022
Z-0499-2023Class IISTRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001November 2, 2022
Z-0549-2023Class IIwww.StradisHealthcare.com, Endovenous Pack, Item No.682-494,November 2, 2022
Z-0526-2023Class IIHENRY SCHEIN, EXTREMITY PACK, Item No.570-2946November 2, 2022
Z-0520-2023Class IIHENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883November 2, 2022