HONEYWELL INC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
69
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0461-2024Class IIEyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge,March 29, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K902230COLORADO COLOR IMAGING RECORDERJune 19, 1990
K863100CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECORFebruary 3, 1987
K853501HONEYWELL ELECTRONIC VENTILATOR EV-AApril 4, 1986
K855125PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEMMarch 26, 1986
K851888APM DISPOS. BLOOD PRESSURE TRANSDUCERAugust 6, 1985
K851496ECG MONITOR MODEL RM102July 24, 1985
K850794PATIENT MONITOR MODEL RM-300April 18, 1985
K851092PORTABLE DEFIBRILLATOR/MONITOR ED 425April 10, 1985
K834530EXTENSION BOX EB200June 1, 1984
K834282ULTRA IMAGER 2000April 23, 1984
K840167PORTABLE DEFIBRILLATORFebruary 4, 1984
K831164PATIENT MONITOR CM 135December 1, 1983
K831696PORTABLE DEFIBRILLATOR MONITOR 74DRKNovember 3, 1983
K831817PATIENT MONITOR #RM-100October 31, 1983
K831818CENTRAL STATION MONITOR CSM-100October 31, 1983
K832212PATIENT SELECTOR FUNCTION BLOCKOctober 14, 1983
K830914EXTERNAL VALVE FUNCTION BLOCKAugust 12, 1983
K830566CONVERTER UNIT FOR ECG TRACE DISPLAYMay 25, 1983
K830779PRESSURE FUNCTION BLOCK FOR BLOOD PRESSMay 9, 1983
K822926MODEL LS-85 & MEDEL 1828 LINESCAN VISCONovember 24, 1982