BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VARIAX

    FDA UDI
    Stryker GmbH·07613327177213·Wrist Tray Clip

    K140347

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

    K140347

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

    ANKYLOS C/X IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SIREMOBIL ISO-C 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·November 13, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·February 3, 2013

    CRYSTALSERT, CRYSTALENS, DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code MSS·December 20, 2010

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·July 17, 2014

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

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

    33CM DORSEY GRASPER FORCEPS, P/N 0250080319. 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

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020