BEUDAMED
    24 results · 16ms · Sources: EU EUDAMED, US FDA

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    Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·November 11, 2020

    Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtronic temporary external pacemakers.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure·Product code LDF·June 16, 2016

    Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtronic temporary external pacemakers.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure·July 20, 2016

    Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWS·January 10, 2011

    Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LWS·September 22, 2020

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Recall
    Terminated ·SA3, LLC·Product code OLR·February 21, 2022

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Enforcement
    Class II ·Terminated·SA3, LLC·April 13, 2022

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Enforcement
    Class II ·Terminated·EMG Technology Co., Ltd.·September 24, 2014

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Recall
    Terminated ·EMG Technology Co., Ltd.·Product code JCX·August 3, 2014

    GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG

    FDA Recall
    Terminated ·General Electric Med Systems·Product code EAM·March 30, 2004

    Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810

    FDA Recall
    Terminated ·Straumann Usa, Llc·Product code EGG·January 10, 2008

    GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA

    FDA Recall
    Terminated ·General Electric Med Systems·Product code EAM·March 30, 2004

    Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.

    FDA Recall
    Terminated ·Selectivemed Components Inc·Product code EGJ·March 15, 2005

    GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256EH

    FDA Recall
    Terminated ·General Electric Med Systems·Product code EAM·March 30, 2004

    GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056EC

    FDA Recall
    Terminated ·General Electric Med Systems·Product code EAM·March 30, 2004

    iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

    FDA Recall
    Terminated ·Tapemark Company·Product code EGJ·November 10, 2021

    Hidrex USA DVP1000

    FDA Recall
    Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017

    Hidrex USA DP450

    FDA Recall
    Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017

    Daavlin Aquex (DAAV1000)

    FDA Recall
    Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017

    Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.

    FDA Recall
    Terminated ·EM Innovations Inc·Product code MMK·April 3, 2006