BEUDAMED
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    DORNIER COMPACT DELTA LITHOTRIPTER

    FDA Adverse Event
    Malfunction ·DORNIER MEDTECH SYSTEMS GMBH·Product code LNS·January 12, 2016

    COE-SOFT 5.5 OZ PROFESSIONAL PACKAGE

    FDA Adverse Event
    Injury ·GC AMERICA INC.·Product code EBI·June 1, 2017

    da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code GDW·April 23, 2018

    da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code GDW·April 23, 2018

    Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·October 2, 2013

    Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·October 2, 2013

    Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code JAK·February 21, 2006

    Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code JAK·February 21, 2006

    C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.

    FDA Recall
    Terminated ·PENTAX of America Inc·Product code GEH·December 3, 2018

    Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electro cautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electro cautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system is indicated for adult and pediatric use

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·November 11, 2013

    Welch Allyn Limited

    Importer
    🇮🇪 Ireland·8 Manufacturers

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices