8 results
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7ms
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Sources: EU EUDAMED, US FDA
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·August 17, 2022
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·NEO METRICS, INC.·June 18, 2014
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
FDA Enforcement
Class II
·Terminated·VEO DIAGNOSTICS, LLC·December 9, 2020
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
FDA Enforcement
Class II
·Terminated·INO Therapeutics (dba Ikaria)·March 11, 2015
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
FDA Enforcement
Class II
·Terminated·INO Therapeutics (dba Ikaria)·February 1, 2017
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
FDA Enforcement
Class II
·Terminated·INO Therapeutics (dba Ikaria)·May 14, 2014
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
FDA Enforcement
Class II
·Terminated·INO Therapeutics (dba Ikaria)·December 17, 2014
Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flow of the nitric oxide in nitrogen compressed gas. The nitric oxide gas is administered to a patient via a nitric oxide delivery device. The amount of time that gas flow administered to a patient is captured in the INOmeter. Each INOmeter is programmed to include the drug product expiration date as listed on the INOflo drug product label. The INOmeter electronically communicates to the nitric oxide delivery device via infrared technology by way of the iButton and in so communicates the expiration date of the corresponding cylinder of INOflo drug product to the delivery device. The delivery device evaluates and compares the expiration date to the current date of therapy administration. If the drug product expiration date is prior to the current date, an error and alarm is registered by the nitric oxide delivery device and administration of the expired drug to the patient is stopped after 120 seconds. If this occurs, the healthcare provider can operate the nitric oxide delivery device manually and deliver the INOflo as indicated in the Instructions For Use (IFU). The INOflo delivery device has the functionality to administer INOflo in manual mode.
FDA Enforcement
Class II
·Terminated·INO therapeutics LLC/dba ikaria·August 15, 2018