Waters Medical Systems LLC

FDA Regulatory Profile

Waters Medical Systems LLC appears in FDA public data with 1 recall, 3 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1013-2022, Class II) was initiated on March 21, 2022. Its most recent 510(k) clearance was granted on August 16, 2013.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1013-2022Class IIWAVES WCM Kidney Cassette ModuleMarch 21, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K121736PERF-GEN PULSATILE PERFUSION SOLUTIONAugust 16, 2013
K121618BEL-GEN COLD STORAGE SOLUTIONJune 14, 2013
K111521WAVESFebruary 16, 2012