BEUDAMED
    79 results · 12ms · Sources: EU EUDAMED, US FDA

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    Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

    FDA Recall
    Terminated ·Alpha Omega Engineering·Product code GZL·September 4, 2018

    Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France.

    FDA Recall
    Terminated ·Bio Rad Laboratories, Inc.·Product code NOM·January 25, 2005

    Platelia Aspergillus EIA

    FDA Recall
    Terminated ·Bio Rad Laboratories, Inc.·Product code NOM·November 6, 2003

    Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    FDA Enforcement
    Class II ·Terminated·Solta Medical Inc·April 15, 2020

    Misys Laboratory version 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·December 20, 2002

    Misys Laboratory versions 5.23 and 5.3

    FDA Recall
    Terminated ·Sunquest Information Systems·November 22, 2002

    DL2000 Data Manager Software, Version 6.4.108

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JQP·November 5, 2004

    EM2 NC AEM Monitor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    EM2M NC AEM Monitor, (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·January 27, 2004

    EM2+A NC AEM Monotor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    Misys Laboratory System version 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·April 1, 2003

    Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·July 6, 2005

    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·April 14, 2010

    Misys Laboratory System, versions 5.2, 5.23 and 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·June 10, 2003

    Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·January 17, 2003

    Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

    FDA Enforcement
    Class III ·Terminated·Philips Electronics North America Corporation·December 27, 2017

    Misys Laboratory versions 5.23 and 5.3 with Callback

    FDA Recall
    Terminated ·Sunquest Information Systems·Product code JQP·October 18, 2002

    Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·October 14, 2020

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013