Cordis US Corp

FDA Regulatory Profile

Summary

Total Recalls
22 (15 Class I)
510(k) Clearances
4
Inspections
10
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1510-2025Class IICordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx OnlyMarch 4, 2025
Z-1511-2025Class IICordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx OnlyMarch 4, 2025
Z-1330-2025Class IIVista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is inteFebruary 7, 2025
Z-0675-2024Class IIMYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoralNovember 28, 2023
Z-0674-2024Class IIMYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral veNovember 28, 2023
Z-0286-2024Class ICordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheterSeptember 26, 2023
Z-1483-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMCMarch 24, 2023
Z-1485-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMCMarch 24, 2023
Z-1489-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RECMarch 24, 2023
Z-1490-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMMarch 24, 2023
Z-1484-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMCMarch 24, 2023
Z-1492-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814REMarch 24, 2023
Z-1487-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMCMarch 24, 2023
Z-1493-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814REMarch 24, 2023
Z-1486-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMCMarch 24, 2023
Z-1494-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMMarch 24, 2023
Z-1488-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MCMarch 24, 2023
Z-1495-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMMarch 24, 2023
Z-1496-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814REMarch 24, 2023
Z-1491-2023Class IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REMarch 24, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K233637Cordis BRITECROSS Support CatheterJune 28, 2024
K232573INFINITI™ Ambi Angiographic CatheterNovember 21, 2023
K230704RAIN Sheath™ Tibial Pedal IntroducerApril 24, 2023
K221832SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterAugust 22, 2022