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Sources: EU EUDAMED, US FDA
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Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
FDA Enforcement
Class II
·Terminated·Animas Corporation·November 5, 2014
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator
FDA Enforcement
Class II
·Terminated·Hologic, Inc·September 14, 2016
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
FDA Enforcement
Class II
·Terminated·Hologic, Inc·September 14, 2016
Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Abbott Molecular·January 9, 2013
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·March 12, 2014
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·December 31, 2014
BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 28, 2019
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
FDA Enforcement
Class II
·Ongoing·Covidien, LLC·July 5, 2023