Cook Medical Llc

FDA Regulatory Profile

Cook Medical Llc appears in FDA public data with 2 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0722-2024, Class II) was initiated on December 7, 2023. Its most recent 510(k) clearance was granted on March 25, 2024.

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Known Names

cook medical, cook, medical

Recent Recalls

NumberClassProductDate
Z-0722-2024Class IIMINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429December 7, 2023
Z-0809-2021Class IIDisposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707December 16, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsMarch 25, 2024