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)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2014 | Hospira 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 |
FRN | K060806 |
| Oct 24, 2014 | Hospira 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 |
FRN | K060806 |
| Oct 21, 2014 | Intra Pump Infusion Systems CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" Terminated |
FRN | K041414 K042085 +3 |
| Oct 1, 2014 | Baxter Healthcare Corp. SPECTRUM Pump, Model No. 35700BAX.
Intended to be used for the controlled administration of intravenous fluids. Terminated |
FRN | K042121 |
| Aug 8, 2014 | Medtronic MiniMed Inc. Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D Terminated |
FRN | None listed |
| Jul 10, 2014 | Hospira 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 |
FRN | K042609 |
| Jul 10, 2014 | Hospira 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 |
FRN | K060806 |
| Jun 3, 2014 | Hospira 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 |
FRN | K952799 |
| Jun 3, 2014 | Hospira 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 |
FRN | K010924 |
| Jun 3, 2014 | Hospira Inc. LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration. Terminated |
FRN | K911401 |
| May 30, 2014 | Bayer 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 |
FRN | K073051 |
| May 16, 2014 | The 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 |
FRN | K030576 |
| May 14, 2014 | CareFusion 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 |
FRN | K950419 |
| May 1, 2014 | Hospira 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 |
FRN | K060806 |
| May 1, 2014 | Hospira 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 |
FRN | K011096 |
| May 1, 2014 | Hospira 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 |
FRN | K991501 |
| Apr 25, 2014 | Baxter 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 |
FRN | K042121 |
| Apr 21, 2014 | Hospira 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 |
FRN | K982159 |
| Mar 3, 2014 | WalkMed 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 |
FRN | K070529 |
| Dec 20, 2013 | CareFusion 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 |
FRN | K041241 K051641 |
| Dec 19, 2013 | Smiths 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 |
FRN | K111386 |
| Nov 21, 2013 | Hospira 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 |
FRN | K083019 |
| Nov 21, 2013 | Hospira 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 |
FRN | K060806 |
| Nov 20, 2013 | Hospira 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 |
FRN | K110901 |
| Nov 14, 2013 | Hospira 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 |
FRN | K042081 |
| Nov 14, 2013 | Hospira 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 |
FRN | K042081 |
| Nov 14, 2013 | Hospira 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 |
FRN | K052052 |
| Nov 14, 2013 | Hospira 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 |
FRN | K070398 |
| Nov 14, 2013 | Hospira 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 |
FRN | K021350 |
| Nov 14, 2013 | Hospira 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 |
FRN | K982159 |
| Nov 14, 2013 | Hospira 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 |
FRN | K042081 |
| Nov 14, 2013 | Hospira 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 |
FRN | K052052 |
| Nov 14, 2013 | Hospira 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 |
FRN | K070398 |
| Nov 14, 2013 | Hospira 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 |
FRN | K021350 |
| Nov 14, 2013 | Hospira 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 |
FRN | K982159 |
| Nov 14, 2013 | Hospira 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 |
FRN | K011442 |
| Nov 14, 2013 | Hospira 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 |
FRN | K011442 |
| Nov 14, 2013 | Hospira 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 |
FRN | K081412 |
| Nov 14, 2013 | Hospira 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 |
FRN | K081412 |
| Nov 8, 2013 | Baxter 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 |
FRN | K042121 |
| Nov 8, 2013 | Baxter Healthcare Corp. SIGMA SPECTRUM Infusion Pump with Master Drug Library.
Intended to be used for the controlled administration of intravenous fluids. Terminated |
FRN | K042121 |
| Sep 13, 2013 | B 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 |
FRN | K011975 K994375 |
| Sep 10, 2013 | B 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 |
FRN | K994375 |
| Sep 6, 2013 | B. Braun Medical, Inc. Outlook Safety Infusion System Burette Set.
For intravenous fluid administration. Terminated |
FRN | K904518 K921860 +1 |
| Sep 6, 2013 | B 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 |
FRN | None listed |
| Sep 6, 2013 | B 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 |
FRN | None listed |
| Aug 20, 2013 | Medtronic 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 |
FRN | K001828 K032005 |
| Aug 2, 2013 | Iradimed 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 |
FRN | K090087 |
| Aug 2, 2013 | CareFusion 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 |
FRN | K051641 |
| Aug 1, 2013 | Hospira 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 |
FRN | K110901 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.