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 19, 2017CareFusion 303, Inc.
Alaris Pump Module model 8100
Terminated
FRNK950419
Jun 19, 2017CareFusion 303, Inc.
Alaris PC Unit, Model 8015
Terminated
FRNK051641
Jun 15, 2017ICU Medical Inc
Plum 360 Infusion System
Terminated
FRNK141789
K161469
Jun 5, 2017Smiths Medical ASD Inc.
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
Terminated
FRNK843772
Jan 26, 2017Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Terminated
FRNK133801
Jan 18, 2017CareFusion 303, Inc.
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module
Terminated
FRNK950419
Dec 30, 2016Hospira Inc., A Pfizer Company
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Terminated
FRNK141789
Nov 11, 2016Bayer Healthcare
PET Infusion Pump
Terminated
FRNK080297
K100798
Nov 7, 2016Bayer Healthcare
MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclea
Terminated
FRNNone listed
Nov 1, 2016CareFusion 303, Inc.
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Terminated
FRNK051641
Sep 28, 2016Baxter Healthcare Corp.
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in
Terminated
FRNK133801
Sep 28, 2016Baxter Healthcare Corp.
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporatio
Terminated
FRNK133801
Sep 28, 2016Baxter Healthcare Corp.
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Me
Terminated
FRNK042121
Sep 6, 2016Hospira Inc.
Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across
Terminated
FRNK081412
Sep 6, 2016Hospira Inc.
Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini
Terminated
FRNK081412
Sep 6, 2016Hospira Inc.
Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum o
Terminated
FRNK081412
Sep 6, 2016Hospira Inc.
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t
Terminated
FRNK081412
Sep 6, 2016Hospira Inc.
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t
Terminated
FRNK081412
Sep 6, 2016Hospira Inc.
Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini
Terminated
FRNK081412
Sep 6, 2016Hospira Inc.
Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic
Terminated
FRNK081412
Sep 6, 2016Hospira Inc.
Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic
Terminated
FRNK081412
Sep 6, 2016Hospira Inc.
Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectr
Terminated
FRNK081412
Aug 8, 2016CareFusion 303, Inc.
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps
Terminated
FRNK023264
Jul 28, 2016Hospira Inc., A Pfizer Company
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Managemen
Terminated
FRNK141102
Jul 18, 2016WalkMed Infusion, LLC
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Terminated
FRNK070529
Jul 18, 2016WalkMed Infusion, LLC
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Terminated
FRNK070529
May 12, 2016CareFusion 303, Inc.
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Terminated
FRNK051641
Mar 25, 2016Hospira Inc.
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, seco
Terminated
FRNK141789
Mar 25, 2016Hospira Inc.
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad
Terminated
FRNK141789
Mar 24, 2016CareFusion 303, Inc.
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Terminated
FRNK051641
Feb 11, 2016MOOG Medical Devices Group
Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000
Terminated
FRNK981816
Jan 11, 2016Bayer Healthcare
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Terminated
FRNK100798
Dec 22, 2015Hospira Inc.
The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in o
Terminated
FRNK110901
Nov 6, 2015WalkMed Infusion, LLC
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
Terminated
FRNK070529
Aug 20, 2015Elite Biomedical Solutions LLC
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100
Terminated
FRNNone listed
Aug 20, 2015Elite Biomedical Solutions LLC
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100
Terminated
FRNNone listed
Aug 14, 2015CareFusion 303, Inc.
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
Terminated
FRNK023264
Jul 24, 2015Medtronic MiniMed Inc.
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
Terminated
FRNNone listed
Jun 16, 2015CareFusion 303, Inc.
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software
Terminated
FRNK051641
Apr 16, 2015Baxter Healthcare Corp
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Mas
Terminated
FRNK133801
Mar 23, 2015CareFusion 303, Inc.
Alaris PC units, Model No. 8015. Infusion pump.
Terminated
FRNK051641
Feb 23, 2015Hospira Inc.
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t
Terminated
FRNK052052
Feb 23, 2015Hospira Inc.
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t
Terminated
FRNK081412
Feb 23, 2015Hospira Inc.
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t
Terminated
FRNK042081
Feb 23, 2015Hospira Inc.
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t
Terminated
FRNK070398
Feb 23, 2015Hospira Inc.
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t
Terminated
FRNK011442
Feb 19, 2015CME America, LLC
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Terminated
FRNK042696
Feb 4, 2015Hospira Inc.
Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and
Terminated
FRNK042081
Nov 24, 2014Hospira Inc.
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term
Terminated
FRNK060806
Nov 24, 2014Hospira Inc.
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term
Terminated
FRNK060806

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