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Pump, Infusion

Regulation 880.5725

2510(k)s in 12 months (849 all time)

24recalls in 12 months (724 all time)

672recalls that name a 510(k)

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Top companies in FRN

Company	510(k)s	Recalls
Baxter Healthcare Corp	51	128
Hospira, Inc.	12	129
Stryker Instruments Div. of Stryker Corporation	0	78
Abbott Laboratories	67	4
Carefusion 303, Inc.	4	61
Icu Medical, Inc.	4	43
Smiths Medical Asd, Inc.	1	42
B.Braun Medical, Inc.	11	22
Y	26	0
Zevex International, Inc.	0	25

Date	Firm and product	Code	Linked 510(k)
Apr 22, 2005	Baxter Healthcare Corp. Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Baxter Healthcare Corporation, D Terminated	FRN	K002679
Mar 3, 2005	Alaris Medical Systems Inc Model 8100 Series Medley Medication Safety System Pump Module Terminated	FRN	K012383 K950419
Jan 28, 2005	Baxter Healthcare Corp. Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green stripe, inner diameter of 0.040'', priming volume 1.7 mL, with a luerlock connect Terminated	FRN	K880733
Jan 26, 2005	Harvard Clinical Technology Harvard 2 Dual Channel Syringe Infusion Pump P/N 2001-001 Terminated	FRN	K952794
Dec 22, 2004	Baxter Healthcare Corp. Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen Terminated	FRN	K002211 K003616
Dec 22, 2004	Baxter Healthcare Corp. Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161and 2M8161R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen Terminated	FRN	K002211 K003616
Dec 22, 2004	Baxter Healthcare Corp. Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen Terminated	FRN	K003616 K961703
Dec 22, 2004	Baxter Healthcare Corp. Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen Terminated	FRN	K010566 K953098
Nov 2, 2004	Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics Infusion Dynamics Power Infuser pump. Model number M100B-3A Terminated	FRN	K030739 K992044
Jul 20, 2004	Medtronic Inc, Neurological & Spinal Division Synchromed II infusion pump Terminated	FRN	None listed
Jul 20, 2004	Abbott Labs GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271 Terminated	FRN	None listed
Jul 20, 2004	Baxter Healthcare Corp. Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen Terminated	FRN	K002211 K003616
Jul 20, 2004	Baxter Healthcare Corp. Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen Terminated	FRN	K002211 K003616
Jul 20, 2004	Baxter Healthcare Corp. Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display Terminated	FRN	K003616 K961703
Jul 20, 2004	Baxter Healthcare Corp. Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display sc Terminated	FRN	K010566 K953098
Jan 29, 2004	Baxter Healthcare Corp. Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore Terminated	FRN	K002679
Sep 11, 2003	Harvard Clinical Technology Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001) Terminated	FRN	K952794
Jul 3, 2003	Deltec, Inc Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software Terminated	FRN	K000842
Jun 27, 2003	Abbott Laboratories HPD/ADD I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 86 different sets listed i Terminated	FRN	K832755 K865059 +3
Jun 5, 2003	Abbott Laboratories HPD/ADD LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port, product 19289 Terminated	FRN	K832755
Apr 3, 2003	I-Flow Corporation Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936 Terminated	FRN	K923875
Apr 1, 2003	Abbott Laboratories Gemstar Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version Terminated	FRN	K974778
Apr 1, 2003	Abbott Laboratories Gemstar 6 Therapy I.V. Infusion Pump, List #: 13100-04; 2.9 Software Version Terminated	FRN	K974778
Apr 1, 2003	Abbott Laboratories Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version Terminated	FRN	K974778

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