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Panels › General Hospital › Product code LHI · Class 2

Set, I.V. Fluid Transfer

Regulation 880.5440

2510(k)s in 12 months (206 all time)

1recalls in 12 months (65 all time)

54recalls that name a 510(k)

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Top companies in LHI

Company	510(k)s	Recalls
Baxter Healthcare Corp	12	26
Baxa Corp.	3	17
B.Braun Medical, Inc.	9	8
Medimop Medical Projects, Ltd.	11	1
West Pharma. Services IL, Ltd.	5	3
Yukon Medical	8	0
Baxa Corp., Sub. of Cook Group, Inc.	7	0
Carmel Pharma Ab.	7	0
Laboratorios Grifols, S.A.	7	0
Abbott Laboratories	5	0

Decided	510(k)	Device and applicant	Code
Sep 12, 1983	K832332	VENTED I.V. TRANSFER NEEDLE Baxa Corp., Sub. of Cook Group, Inc.	LHI
Sep 12, 1983	K832312	I.V. TRANSFER NEEDLE Baxa Corp., Sub. of Cook Group, Inc.	LHI
Apr 18, 1983	K830836	Q.C. TESTER Alltek Filtration, Inc.	LHI
Apr 12, 1983	K830970	DOUBLE LUMEN TRANSFER DEVICE Codan Trading Co.	LHI
Apr 26, 1982	K820937	ACKRAD FLUID CONNECTING SET Ackrad Laboratories	LHI
Dec 30, 1981	K812928	VACU-FIL TRANSFER SET American Pharmaseal Div. Ahsc	LHI

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