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

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

    Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.

    FDA Enforcement
    Class II ·Terminated·Alfa Wassermann, Inc.·May 7, 2014

    Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.

    FDA Enforcement
    Class II ·Terminated·Alfa Wassermann, Inc.·May 7, 2014

    Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.

    FDA Enforcement
    Class II ·Terminated·Alfa Wassermann, Inc.·February 6, 2013

    Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·March 2, 2016

    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.

    FDA Enforcement
    Class II ·Terminated·LED Technologies, LLC·May 4, 2016

    UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

    FDA Enforcement
    Class II ·Terminated·Unistrip Technologies LLC·December 31, 2014

    Xoran MiniCAT X-ray imaging device

    FDA Enforcement
    Class II ·Terminated·Xoran Technologies, LLC·March 11, 2015

    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    FDA Enforcement
    Class II ·Terminated·Rymed Technologies, LLC·January 27, 2016

    InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    FDA Enforcement
    Class II ·Terminated·Rymed Technologies, LLC·January 27, 2016

    ARCH Leg Positioning System

    FDA Enforcement
    Class II ·Terminated·Innovative Orthopedic Technologies, LLC·October 13, 2021

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Enforcement
    Class II ·Terminated·X-NAV Technologies, LLC·April 20, 2016

    OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices

    FDA Enforcement
    Class II ·Terminated·Innovative Sterlization Technologies LLC·October 28, 2015

    DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

    FDA Enforcement
    Class II ·Terminated·KaVo Dental Technologies LLC·May 29, 2019

    v|tome|x L Series non-destructive testing cabinet x-ray systems

    FDA Enforcement
    Class II ·Terminated·Ge Inspection Technologies Llc·November 25, 2020

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014