12 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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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 administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corp.·April 30, 2014
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 19, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·October 28, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·October 28, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·October 28, 2020
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 23, 2025
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 23, 2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 12, 2025
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 19, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·February 9, 2022
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018
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 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·June 20, 2012