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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-1070-2020Class IICenturion- Biopsy Tray TRIBT170 BIOPSY TRAYDecember 11, 2019
Z-1088-2020Class IICenturion- OR2020 BASIN SETDecember 11, 2019
Z-1048-2020Class IICenturion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1December 11, 2019
Z-1051-2020Class IICenturion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYDecember 11, 2019
Z-1058-2020Class IICenturion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSELDecember 11, 2019
Z-1065-2020Class IICenturion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAIDecember 11, 2019
Z-1056-2020Class IICenturion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC007December 11, 2019
Z-1066-2020Class IICenturion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TDecember 11, 2019
Z-1072-2020Class IICenturion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHTDecember 11, 2019
Z-1062-2020Class IICenturion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSYDecember 11, 2019
Z-1075-2020Class IICenturion-Suture Tray DYNDR1210A SUTURING TRAYDecember 11, 2019
Z-1085-2020Class IICenturion- Port Draw Kit KNV30 PORT DRAW KITDecember 11, 2019
Z-1064-2020Class IICenturion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETYDecember 11, 2019
Z-1078-2020Class IICenturion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILEDecember 11, 2019
Z-1061-2020Class IICenturion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSDecember 11, 2019
Z-1095-2020Class IICenturion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEDecember 11, 2019
Z-1082-2020Class IICenturion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)December 11, 2019
Z-1043-2020Class IICenturion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY December 11, 2019
Z-1046-2020Class IICenturion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690December 11, 2019
Z-1086-2020Class IICenturion- LC145 STERILE NICU LINE CHANGE KITDecember 11, 2019

Recent 510(k) Clearances

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