Lidco Ltd

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0756-2021Class IICM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to aNovember 19, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K163334LiDCOunity v2 Hemodynamic MonitorJune 5, 2017
K152935LiDCOunity MonitorMarch 17, 2016
K131048LIDCO CNAP MODULEAugust 28, 2013
K122247LIDCORAPID V2 MONITORMarch 20, 2013
K023960LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70January 9, 2003
K010049PULSECO HEMODYNAMIC MONITOR CM71June 14, 2001
K962918LIDCO SYSTEMJanuary 8, 1999