ClearanceBrief
Panels › General Hospital › Product code FRN · Class 2

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

DateFirm and productCodeLinked 510(k)
Jun 27, 2013Baxter Healthcare Corp.
Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h
Terminated
FRNK884505
Jun 27, 2013Baxter Healthcare Corp.
Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Terminated
FRNK884505
Jun 27, 2013Baxter Healthcare Corp.
Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
Terminated
FRNK910425
Jun 27, 2013Baxter Healthcare Corp.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Terminated
FRNK910425
Apr 30, 2013Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered
Terminated
FRNK083019
Apr 30, 2013Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered
Terminated
FRNK060806
Apr 26, 2013Hospira Inc.
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is r
Terminated
FRNK060806
K083019
Apr 26, 2013Hospira Inc.
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is
Terminated
FRNK060806
K083019
Apr 15, 2013Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered
Terminated
FRNK060806
K083019
Apr 15, 2013Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered
Terminated
FRNK060806
K083019
Apr 15, 2013Carefusion Corporation
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Terminated
FRNK051641
Apr 15, 2013Carefusion Corporation
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Terminated
FRNK051641
Mar 26, 2013Smiths Medical ASD, Inc.
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Terminated
FRNK040899
Mar 8, 2013Hospira Inc.
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including
Terminated
FRNK912928
Feb 5, 2013Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Terminated
FRNK110901
Feb 5, 2013Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Terminated
FRNK110901
Feb 4, 2013Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutr
Terminated
FRNK110901
Feb 4, 2013Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nut
Terminated
FRNK110901
Feb 4, 2013Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutr
Terminated
FRNK041550
K110901
Feb 4, 2013Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutr
Terminated
FRNK041550
K110901
Dec 31, 2012B. Braun Medical, Inc.
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
Terminated
FRNK062700
K083689
Dec 31, 2012Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric t
Terminated
FRNK081412
Dec 31, 2012Hospira Inc.
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software ve
Terminated
FRNK021350
K042081 +1
Dec 31, 2012Hospira Inc.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391
Terminated
FRNK011442
K042081 +2
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly
Terminated
FRNK073051
Dec 7, 2012Hospira Inc.
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet soft
Terminated
FRNK042081
Dec 7, 2012Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNe
Terminated
FRNK081412
Dec 7, 2012Hospira Inc.
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module li
Terminated
FRNK011442
K031185 +3
Nov 28, 2012Iradimed Corporation
The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusio
Terminated
FRNK050301
Oct 19, 2012Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general p
Terminated
FRNK041550
K110901
Oct 19, 2012Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general p
Terminated
FRNK041550
K110901
Oct 17, 2012MOOG Medical Devices Group
***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposab
Terminated
FRNK981816
Oct 12, 2012Belmont Instrument Corporation
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
Terminated
FRNK032674
K091855 +1
Aug 24, 2012Baxter Healthcare Corp.
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage:
Terminated
FRNK930459
Aug 24, 2012Baxter Healthcare Corp.
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate d
Terminated
FRNK930459
Aug 17, 2012CareFusion 303, Inc.
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, bl
Terminated
FRNK950419
Aug 15, 2012CareFusion 303, Inc.
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using
Terminated
FRNK950419
Aug 1, 2012Smiths Medical ASD, Inc.
Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use
Terminated
FRNK111386
Jul 26, 2012CareFusion 303, Inc.
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Terminated
FRNK051641
Jul 18, 2012Sigma
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Terminated
FRNK042121
Jul 16, 2012B. Braun Medical, Inc.
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics
Terminated
FRNK062700
K083689
Jun 13, 2012Baxter Healthcare Corporation
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103
Terminated
FRNK042121
May 4, 2012Hospira Inc.
LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number
Terminated
FRNK865060
Apr 26, 2012Hospira Inc.
GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027
Terminated
FRNK023062
K042980 +3
Apr 13, 2012MOOG Medical Devices Group
Epidural Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user access
Terminated
FRNNone listed
Apr 13, 2012MOOG Medical Devices Group
Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron Filter ASV Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user access
Terminated
FRNNone listed
Apr 13, 2012MOOG Medical Devices Group
Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Needleless Injection Port Positive Pressure Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administra
Terminated
FRNNone listed
Apr 13, 2012MOOG Medical Devices Group
Non-Vented Bag Spike, Microbore tubing w/free-flow protection, slide clamp ASV The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide
Terminated
FRNNone listed
Apr 13, 2012MOOG Medical Devices Group
Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provid
Terminated
FRNNone listed
Apr 13, 2012MOOG Medical Devices Group
Non-DEHP Epidural Administration Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and use
Terminated
FRNNone listed

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