43 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples)
FDA Recall
Terminated
·Diasorin Inc.·Product code JNO·February 15, 2007
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JNO·September 25, 2017
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
FDA Enforcement
Class II
·Terminated·Philips Visicu·May 4, 2016
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
FDA Recall
Terminated
·Philips Visicu·Product code DRG·March 10, 2016
Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010
FDA Recall
Terminated
·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010
Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010
AUTION HYBRID AU-4050
FDA Enforcement
Class II
·Terminated·Arkray Factory USA, Inc.·June 26, 2019
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
FDA Enforcement
Class II
·Terminated·Haemonetics Corporation·February 5, 2020
High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
FDA Enforcement
Class II
·Terminated·Haemonetics Corporation·February 5, 2020
AUTION HYBRID AU-4050
FDA Recall
Terminated
·Arkray Factory USA, Inc.·Product code KQO·May 3, 2019
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.
FDA Enforcement
Class II
·Terminated·Haemonetics Corporation·February 5, 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