Panels › General Hospital › Product code FPB · Class 2

Filter, Infusion Line

Regulation 880.5440

1510(k)s in 12 months (99 all time)

0recalls in 12 months (8 all time)

3recalls that name a 510(k)

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Top companies in FPB

Company	510(k)s	Recalls
Abbott Laboratories	11	0
Tri-Med, Inc.	8	0
Millipore Corp.	2	5
Pall Biomedical Products Co.	7	0
Alltek, Inc.	4	0
Baxter Healthcare Corp	4	0
Jelco Laboratories	4	0
Travenol Laboratories, S.A.	4	0
Churchill Corp.	3	0
Gelman Sciences, Inc.	3	0

Decided	510(k)	Device and applicant	Code
Apr 9, 1985	K850826	POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96 Pall Biomedical Products Co.	FPB
Apr 9, 1985	K850825	AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR Pall Biomedical Products Co.	FPB
Oct 9, 1984	K842399	48 HOUR SET CHANGES Tri-Med, Inc.	FPB
Jun 28, 1984	K842075	CRITIKON I.V. FILTER Critikon Company, LLC	FPB
May 21, 1984	K841280	SOLOPAK BRAND FILTER NEEDLE W/5 MICRO Smith & Nephew, Mpl Division	FPB
May 11, 1984	K834376	FILTRARE TM ALLVENT TM Alltek, Inc.	FPB
Apr 24, 1984	K834381	POSIDYNE I.V. FILTER/AIR ELIMINATOR Pall Biomedical Products Co.	FPB
Apr 20, 1984	K840248	IV-FILTER Tri-Med, Inc.	FPB
Dec 27, 1983	K833684	IVEX-INT Abbott Laboratories	FPB
Oct 4, 1983	K832952	MILLIPORE IVEX INT FILTER UNIT Millipore Corp.	FPB
Sep 20, 1983	K831882	POSIDYNE SOLUTION CONTAINER FILTER Pall Biomedical Products Co.	FPB
Aug 16, 1983	K831668	CONTINU-FLO SOLUTION ADMINISTRATION Travenol Laboratories, S.A.	FPB
Aug 12, 1983	K831350	IVFLO-HP & IVFIL-HP FILTER Tri-Med, Inc.	FPB
Aug 12, 1983	K831315	TRILEX Tri-Med, Inc.	FPB
Dec 28, 1982	K823690	IVFLO-HP & IVFIL-HP Tri-Med, Inc.	FPB
Jul 30, 1982	K821013	IVEX-HP PEDIATRIC EXTENSION SET-SL Abbott Laboratories	FPB
Jan 5, 1982	K813454	I.V. FILTER-PREVENT Pioneer Viggo, Inc.	FPB
Jan 5, 1982	K813446	IV FILTERSET 0.22 MICROMETER Imed Corp.	FPB
Jan 5, 1982	K813445	IV FILTERSET 5 MICROMETER Imed Corp.	FPB
Nov 6, 1981	K813001	FIBRI-FILTER 20 Tri-Med, Inc.	FPB
Sep 21, 1981	K812457	HIFLO-HP Tri-Med, Inc.	FPB
Jul 13, 1981	K811773	BACTAGARD Tri-Med, Inc.	FPB
Mar 27, 1981	K810113	TERFUSION FINAL FILTER SET Terumo Medical Corp.	FPB
Jan 21, 1981	K802765	ACRODISC FILTER ASSEMBLY Gelman Sciences, Inc.	FPB
Aug 27, 1980	K801602	DESERET I.V. FILTER Hospital Products Co.	FPB
Aug 13, 1980	K801614	MODEL 40-30-2 AIR ELIMINATING FILTER SET Y	FPB
Aug 12, 1980	K801605	BIMECO FILTERED EXTENSION SET Burron Medical Products, Inc.	FPB
Jun 20, 1980	K801343	B-D FILTER NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic	FPB
Dec 20, 1979	K792510	MICROBAR MONITORING LINE FILTER Medex, Inc.	FPB
Nov 13, 1979	K791822	BIOGUARD INFUSION LINE FILTER United States Surgical, A Division of Tyco Healthc	FPB
Oct 26, 1979	K792021	LARGE VOLUME 5 MICRON CONICAL FILTER National Patent Development Corp.	FPB
Oct 26, 1979	K791809	BLOOD TRANSFUSION MICROFILTER Pioneer Viggo, Inc.	FPB
Jun 1, 1979	K790879	ULTIPOR SOLUTION CONTAINER FILTER Pall Biomedical Products Co.	FPB
Apr 30, 1979	K790471	*JELCO DISC FILTER-0.2 MICRON** Jelco Laboratories	FPB
Mar 6, 1979	K790314	FLUID ADMINISTRATION SETS, 15 MICRON Medex, Inc.	FPB
Feb 27, 1979	K781815	HEMO-NATE SYRINGE BLOOD FILTER Gisco Intl.	FPB
Jan 26, 1978	K772312	FILTERSET W/Y-INJECTION SITE, 0.2 Abbott Laboratories	FPB
Jan 3, 1978	K771972	5UM FILTERSET WITH Y-INJECTION SITE Abbott Laboratories	FPB
Oct 25, 1977	K771536	AIR VENT FILTER NEEDLE, 0.45 Jelco Laboratories	FPB
Oct 13, 1977	K771862	TRANSFUSION BLOOD FILTER Medical, Inc.	FPB
Oct 13, 1977	K771827	INTRAVENOUS FILTER W/FLASH BULB Jelco Laboratories	FPB
Oct 13, 1977	K771826	INTRAVENOUS FILTER W/AUTO AIR VENT Jelco Laboratories	FPB
Sep 28, 1977	K771594	PRIMARY PIGGYBACK VENOSET W/ FILTER Abbott Laboratories	FPB
Sep 20, 1977	K771430	BLOOD FILTER, W/SET Terumo America, Inc.	FPB
Aug 19, 1977	K771498	CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET Travenol Laboratories, S.A.	FPB
Jun 14, 1977	K770843	IV PUMP FILTERSET, UNIVERSAL Abbott Laboratories	FPB
Jun 14, 1977	K770703	FILTER UNIT, SINGLE USE Millipore Corp.	FPB
Mar 15, 1977	K770182	0.22/UM FILTERSET W/Y-INJECTION SITE Abbott Laboratories	FPB
Feb 9, 1977	K770183	O.22/UM FILTERSET W/FLASHBACK Abbott Laboratories	FPB

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