44 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Belos DR-T Implantable Cardioverter Defibrillator
FDA Recall
Terminated
·Biotronik Inc·Product code LWS·September 24, 2003
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code NJL·November 29, 2017
BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code LWS·March 8, 2021
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000.
FDA Recall
Terminated
·Ansar Group, Inc. Dba Ansar Medical Technologies, Inc·Product code DRT·July 1, 2014
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
FDA Recall
Terminated
·Datascope Corp·Product code DRT·June 16, 2005
Vios Monitoring System Bedside Monitor Model BSM2050
FDA Recall
Open, Classified
·Murata Vios, Inc.·Product code DRT·August 9, 2024
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
FDA Recall
Terminated
·Datascope Corp·Product code DRT·August 19, 2005
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
FDA Recall
Completed
·Murata Vios, Inc.·Product code DRT·June 21, 2021
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
FDA Recall
Open, Classified
·Murata Vios, Inc.·Product code DRT·June 6, 2023
Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature , and gases (i.e. five anesthetsia gases, O2, N2O, and CO2)
FDA Recall
Terminated
·Datascope Corp·Product code DRT·September 7, 2005
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
FDA Recall
Terminated
·Datascope Corp·Product code DRT·July 28, 2004
V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices
FDA Recall
Terminated
·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code DRT·October 14, 2011