910 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
FDA Enforcement
Class II
·Terminated·Arrow International Inc·December 25, 2019
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
FDA Enforcement
Class II
·Terminated·Arrow International Inc·December 25, 2019
Myriad handpiece Tissue morcellator
FDA Enforcement
Class II
·Terminated·Nico Corp.·June 29, 2016
Alinity i Progesterone Reagent Kit, List Number 08P3620
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Elekta Precise Treatment Table
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 25, 2015
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
FDA Enforcement
Class II
·Terminated·Carefusion 303 Inc·February 27, 2013
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
FDA Enforcement
Class I
·Terminated·Del Mar Reynolds Medical, Ltd.·April 23, 2014
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·October 1, 2014
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·January 2, 2019
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·March 4, 2015
Alinity i TSH Reagent Kit, List Number 07P4830
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
FDA Enforcement
Class I
·Terminated·LivaNova USA Inc·January 1, 2020
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·June 27, 2012
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·June 18, 2014
Plum 360 Infusion System, List number 30010.
FDA Enforcement
Class II
·Terminated·ICU Medical Inc·November 22, 2017
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Enforcement
Class II
·Terminated·HeartWare Inc·May 21, 2014
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·September 24, 2014
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
FDA Enforcement
Class II
·Terminated·Handicare AB·October 18, 2017