HILL-ROM MANUFACTURING, INC.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0484-2021Class IILife2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118November 12, 2020
Z-0192-2018Class IIMonarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability onSeptember 15, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K080226NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912April 9, 2008
K032772MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCOctober 8, 2003
K031387ISOLETTE INFANT INCUBATOR, MODEL C2000EAugust 1, 2003
K014094MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEMJanuary 11, 2002