ClearanceBrief
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

Company510(k)sRecalls
Abbott Laboratories110
Tri-Med, Inc.80
Millipore Corp.25
Pall Biomedical Products Co.70
Alltek, Inc.40
Baxter Healthcare Corp40
Jelco Laboratories40
Travenol Laboratories, S.A.40
Churchill Corp.30
Gelman Sciences, Inc.30
DateFirm and productCodeLinked 510(k)
Apr 21, 2021Smiths Medical ASD Inc.
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
Terminated		 FPBK961404
Dec 13, 2017Halyard Health, Inc
CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients
Terminated		 FPBK083210
Jun 30, 2011Pall Life Sciences Puerto Rico Llc
Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candid
Terminated		 FPBK905794
Jul 20, 2004Millipore Corp.
Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS
Terminated		 FPBNone listed
Jul 20, 2004Millipore Corp.
Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS
Terminated		 FPBNone listed
Jul 20, 2004Millipore Corp.
Millex-AA Syringe Driven Filter 0.8 um, Sterile Catalog Number: SLAAM33SS
Terminated		 FPBNone listed
Jul 20, 2004Millipore Corp.
Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile Catalog Number: SLHAM33SS
Terminated		 FPBNone listed
Jul 20, 2004Millipore Corp.
Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog Number: SLGSM33SS
Terminated		 FPBNone listed

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