BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016

    Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016

    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·March 25, 2020

    Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel's ability to perform the procedure and to properly interpret the microscopic test results.

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·July 11, 2012

    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.

    FDA Enforcement
    Class II ·Terminated·BTE Technologies, Inc.·July 15, 2015

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018

    Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

    FDA Enforcement
    Class II ·Terminated·TP Orthodontics, Inc.·May 16, 2018