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-0533-2023Class IIHENRY SCHEIN, Labiaplasty PackItem No.570-3118,November 2, 2022
Z-0543-2023Class IISTRADIS HEALTHCARE, Vein, Item No.682-1732,November 2, 2022
Z-0540-2023Class IISTRADIS HEALTHCARE, Phleb, Item No.682-1425,November 2, 2022
Z-0504-2023Class IIHENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery trayNovember 2, 2022
Z-0496-2023Class IISTRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dentalNovember 2, 2022
Z-0522-2023Class IIHENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891November 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-0534-2023Class IIHENRY SCHEIN, ILR Insertion Tray, Item No.570-3131November 2, 2022
Z-0508-2023Class IIHENRY SCHEIN, Basin Set, Item No.570-1803November 2, 2022
Z-0523-2023Class IIHENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,November 2, 2022
Z-0539-2023Class IISTRADIS HEALTHCARE, Ablation Pack, Item No.682-130,November 2, 2022
Z-0526-2023Class IIHENRY SCHEIN, EXTREMITY PACK, Item No.570-2946November 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-0537-2023Class IISTRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,November 2, 2022
Z-0521-2023Class IIHENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890November 2, 2022
Z-0551-2023Class IISTRADIS HEALTHCARE, Vein, Item No.682-577,November 2, 2022