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Alaris Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K043299MEDLEY PCA MODULE, MODEL 8120December 10, 2004
K041241MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600July 6, 2004
K031741MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300February 9, 2004
K032233MEDLEY PCA MODULE, MODEL 8120September 9, 2003
K032147SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXJuly 25, 2003
K030459MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)April 4, 2003
K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110December 19, 2002
K022677MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLESeptember 11, 2002
K022209ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETSAugust 6, 2002
K013087SINGLE DOSE DISPENSING PIN, MODEL 2201November 13, 2001
K012383GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII),October 2, 2001
K010965A-LINE AEP MONITORJune 27, 2001
K010966MEDLEY SP02 MODULE, MODEL 8220June 8, 2001
K993524ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETSAugust 1, 2000
K983626KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ IIFebruary 5, 1999
K974332VARIABLE PRESSURE SYRINGE PUMPDecember 29, 1998