BEUDAMED
    199 results · 13ms · Sources: EU EUDAMED, US FDA

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    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 For implantation in humans to treat Epilepsy and Depression.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·August 12, 2011

    The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***STERILE R STERILE EO***PVC, BRASS***WARNING: DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS. FIRE COULD RESULT.***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA***#915-3100 LOT***QTY 00001, HEAT/CONTOURING PEN AND TIPS***PVC, BRASS***". Product Usage: Two tips are provided with the body of the device to cut / contour the edges of the LactoSorb plates by heating the material.

    FDA Recall
    Terminated ·Biomet Microfixation, LLC·Product code IRQ·November 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr. ID/ 7.7 OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr. ID/ 6.90 OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-73-ZT, REF G48478, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48473, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48470, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-56-ZT, REF G48465, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-30-82-ZT, REF G48422, 20 Fr ID/ 7.7 mm OD

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48477, 16Fr ID/ 6.0 mm OD, Sterile.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·April 15, 2011