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)
Oct 24, 2014Hospira Inc.
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120
Terminated
FRNK060806
Oct 24, 2014Hospira Inc.
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120
Terminated
FRNK060806
Oct 21, 2014Intra Pump Infusion Systems
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Terminated
FRNK041414
K042085 +3
Oct 1, 2014Baxter Healthcare Corp.
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
Terminated
FRNK042121
Aug 8, 2014Medtronic MiniMed Inc.
Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
Terminated
FRNNone listed
Jul 10, 2014Hospira Inc.
The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible comp
Terminated
FRNK042609
Jul 10, 2014Hospira Inc.
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and
Terminated
FRNK060806
Jun 3, 2014Hospira Inc.
Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and paren
Terminated
FRNK952799
Jun 3, 2014Hospira Inc.
Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general
Terminated
FRNK010924
Jun 3, 2014Hospira Inc.
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
Terminated
FRNK911401
May 30, 2014Bayer Corp
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intend
Terminated
FRNK073051
May 16, 2014The Anspach Effort, Inc.
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and
Terminated
FRNK030576
May 14, 2014CareFusion 303, Inc.
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under th
Terminated
FRNK950419
May 1, 2014Hospira Inc.
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosti
Terminated
FRNK060806
May 1, 2014Hospira Inc.
Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration se
Terminated
FRNK011096
May 1, 2014Hospira Inc.
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fl
Terminated
FRNK991501
Apr 25, 2014Baxter Healthcare Corp.
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administr
Terminated
FRNK042121
Apr 21, 2014Hospira Inc.
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use
Terminated
FRNK982159
Mar 3, 2014WalkMed Infusion, LLC
Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nu
Terminated
FRNK070529
Dec 20, 2013CareFusion 303, Inc.
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply
Terminated
FRNK041241
K051641
Dec 19, 2013Smiths Medical ASD, Inc.
Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pu
Terminated
FRNK111386
Nov 21, 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
Nov 21, 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
Nov 20, 2013Hospira Inc.
*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along
Terminated
FRNK110901
Nov 14, 2013Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf
Terminated
FRNK042081
Nov 14, 2013Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 I
Terminated
FRNK042081
Nov 14, 2013Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 I
Terminated
FRNK052052
Nov 14, 2013Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf
Terminated
FRNK070398
Nov 14, 2013Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 I
Terminated
FRNK021350
Nov 14, 2013Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf
Terminated
FRNK982159
Nov 14, 2013Hospira Inc.
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use w
Terminated
FRNK042081
Nov 14, 2013Hospira Inc.
Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general
Terminated
FRNK052052
Nov 14, 2013Hospira Inc.
Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general
Terminated
FRNK070398
Nov 14, 2013Hospira Inc.
Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the
Terminated
FRNK021350
Nov 14, 2013Hospira Inc.
Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general
Terminated
FRNK982159
Nov 14, 2013Hospira Inc.
Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general
Terminated
FRNK011442
Nov 14, 2013Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf
Terminated
FRNK011442
Nov 14, 2013Hospira Inc.
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The
Terminated
FRNK081412
Nov 14, 2013Hospira Inc.
Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise d
Terminated
FRNK081412
Nov 8, 2013Baxter Healthcare Corp.
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intr
Terminated
FRNK042121
Nov 8, 2013Baxter Healthcare Corp.
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Terminated
FRNK042121
Sep 13, 2013B Braun Medical, Inc.
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system i
Terminated
FRNK011975
K994375
Sep 10, 2013B Braun Medical, Inc.
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system i
Terminated
FRNK994375
Sep 6, 2013B. Braun Medical, Inc.
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Terminated
FRNK904518
K921860 +1
Sep 6, 2013B Braun Medical, Inc.
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system i
Terminated
FRNNone listed
Sep 6, 2013B Braun Medical, Inc.
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system i
Terminated
FRNNone listed
Aug 20, 2013Medtronic MiniMed
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm ser
Terminated
FRNK001828
K032005
Aug 2, 2013Iradimed Corporation
MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or
Terminated
FRNK090087
Aug 2, 2013CareFusion 303, Inc.
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris Sys
Terminated
FRNK051641
Aug 1, 2013Hospira Inc.
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-ar
Terminated
FRNK110901

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