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-0551-2023Class IISTRADIS HEALTHCARE, Vein, Item No.682-577,November 2, 2022
Z-0490-2023Class IISTRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery trayNovember 2, 2022
Z-0495-2023Class IISTRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,November 2, 2022
Z-0537-2023Class IISTRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,November 2, 2022
Z-0533-2023Class IIHENRY SCHEIN, Labiaplasty PackItem No.570-3118,November 2, 2022
Z-0549-2023Class IIwww.StradisHealthcare.com, Endovenous Pack, Item No.682-494,November 2, 2022
Z-0499-2023Class IISTRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001November 2, 2022
Z-0513-2023Class IIHENRY SCHEIN, VEIN TRAY, Item No.570-2738,November 2, 2022
Z-0522-2023Class IIHENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891November 2, 2022
Z-0505-2023Class IIHENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482November 2, 2022
Z-0510-2023Class IIHENRY SCHEIN, GYN PACK, Item No.570-2625November 2, 2022
Z-0500-2023Class IISTRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascularNovember 2, 2022
Z-0528-2023Class IIHENRY SCHEIN, RHINO PACK, Item No.570-3070November 2, 2022
Z-0530-2023Class IIHENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089November 2, 2022
Z-0542-2023Class IISTRADIS HEALTHCARE, Surgery PK, Item No.682-1728,November 2, 2022
Z-0511-2023Class IIHENRY SCHEIN, ENT PACK, Item No.570-2718November 2, 2022
Z-0502-2023Class IIHENRY SCHEIN, Breast Augmentation tray, Item No.570-0611November 2, 2022
Z-0497-2023Class IISurgical room, DENTAL SURGICAL PACK, Item No.41236SDSPNovember 2, 2022
Z-0556-2023Class IIHENRY SCHEIN, Vas Pack, Item No.888-2520,November 2, 2022