BEUDAMED
    10,000 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement × Classification: Class Ii × Clear all

    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

    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

    Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019