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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-0491-2023Class IISTRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery trayNovember 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-0521-2023Class IIHENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890November 2, 2022
Z-0503-2023Class IIHENRY SCHEIN, Vein Clinics 1, Item No.570-1426November 2, 2022
Z-0528-2023Class IIHENRY SCHEIN, RHINO PACK, Item No.570-3070November 2, 2022
Z-0505-2023Class IIHENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482November 2, 2022
Z-0537-2023Class IISTRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,November 2, 2022
Z-0517-2023Class IIHENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787November 2, 2022
Z-0549-2023Class IIwww.StradisHealthcare.com, Endovenous Pack, Item No.682-494,November 2, 2022
Z-0504-2023Class IIHENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery trayNovember 2, 2022
Z-0519-2023Class IIHENRY SCHEIN, PACEMAKER PACK IItem No.570-2793November 2, 2022
Z-0492-2023Class IISurgical room, SURGICAL PACK, Item No.40996WLS, oral surgery trayNovember 2, 2022
Z-0525-2023Class IIHENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930November 2, 2022
Z-0520-2023Class IIHENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883November 2, 2022
Z-0547-2023Class IISTRADIS HEALTHCARE, Medical Vein, Item No.682-330,November 2, 2022
Z-0501-2023Class IISTRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery trayNovember 2, 2022
Z-0490-2023Class IISTRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery trayNovember 2, 2022
Z-0496-2023Class IISTRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dentalNovember 2, 2022
Z-0534-2023Class IIHENRY SCHEIN, ILR Insertion Tray, Item No.570-3131November 2, 2022