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Company · US

Alaris Medical Systems, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2004. Name variants (Inc, Corp, punctuation) are merged.

16510(k) clearances (0 in 12 months)

1recalls (0 in 12 months)

1recalls that name a 510(k)

Product codes

Code	Device	Records
FRN	Pump, Infusion	8
DQA	Oximeter	2
MEA	Pump, Infusion, Pca	2
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	1
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	1
FPA	Set, Administration, Intravascular	1
LHI	Set, I.V. Fluid Transfer	1
OLW	Index-Generating Electroencephalograph Software	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Dec 10, 2004	K043299	MEDLEY PCA MODULE, MODEL 8120 Alaris Medical Systems, Inc.	MEA
Jul 6, 2004	K041241	MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 Alaris Medical Systems, Inc.	FRN
Feb 9, 2004	K031741	MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 Alaris Medical Systems, Inc.	CCK
Sep 9, 2003	K032233	MEDLEY PCA MODULE, MODEL 8120 Alaris Medical Systems, Inc.	MEA
Jul 25, 2003	K032147	SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES Alaris Medical Systems, Inc.	FRN
Apr 4, 2003	K030459	MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) Alaris Medical Systems, Inc.	FRN
Dec 19, 2002	K023264	MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 Alaris Medical Systems, Inc.	FRN
Sep 11, 2002	K022677	MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE Alaris Medical Systems, Inc.	DQA
Aug 6, 2002	K022209	ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS Alaris Medical Systems, Inc.	FPA
Nov 13, 2001	K013087	SINGLE DOSE DISPENSING PIN, MODEL 2201 Alaris Medical Systems, Inc.	LHI
Oct 2, 2001	K012383	GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C Alaris Medical Systems, Inc.	FRN
Jun 27, 2001	K010965	A-LINE AEP MONITOR Alaris Medical Systems, Inc.	OLW
Jun 8, 2001	K010966	MEDLEY SP02 MODULE, MODEL 8220 Alaris Medical Systems, Inc.	DQA
Aug 1, 2000	K993524	ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS Alaris Medical Systems, Inc.	FRN
Feb 5, 1999	K983626	KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II Alaris Medical Systems, Inc.	DXH
Dec 29, 1998	K974332	VARIABLE PRESSURE SYRINGE PUMP Alaris Medical Systems, Inc.	FRN

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Mar 3, 2005	Alaris Medical Systems Inc Model 8100 Series Medley Medication Safety System Pump Module Terminated	FRN	K012383 K950419

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