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Centurion Medical Products Corporation

FDA Regulatory Profile

Summary

Total Recalls
152 (2 Class I)
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1065-2020Class IICenturion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAIDecember 11, 2019
Z-1051-2020Class IICenturion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYDecember 11, 2019
Z-1070-2020Class IICenturion- Biopsy Tray TRIBT170 BIOPSY TRAYDecember 11, 2019
Z-1076-2020Class IICenturion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCIDecember 11, 2019
Z-1082-2020Class IICenturion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)December 11, 2019
Z-1056-2020Class IICenturion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC007December 11, 2019
Z-1064-2020Class IICenturion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETYDecember 11, 2019
Z-1058-2020Class IICenturion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSELDecember 11, 2019
Z-1068-2020Class IICenturion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790December 11, 2019
Z-1090-2020Class IICenturion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAYDecember 11, 2019
Z-1095-2020Class IICenturion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEDecember 11, 2019
Z-1084-2020Class IICenturion IVS3505 ULTRASOUND GUIDED PIV KITDecember 11, 2019
Z-1052-2020Class IICenturion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDUDecember 11, 2019
Z-1050-2020Class IICenturion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EDecember 11, 2019
Z-1043-2020Class IICenturion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY December 11, 2019
Z-1091-2020Class IICenturion- ENT SNUF3 SNUFFER KIT YDecember 11, 2019
Z-1069-2020Class IICenturion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7December 11, 2019
Z-1077-2020Class IICenturion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLEDecember 11, 2019
Z-1047-2020Class IICenturion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPADecember 11, 2019
Z-1048-2020Class IICenturion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1December 11, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K161408Compass Cast and MAPNovember 22, 2016
K103562CENTURION PRESSURE INJECTABLE EXTENSION SETJune 23, 2011