BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    InstruSafe(R) Sterilization Container

    FDA 510(k)
    FDA Class 2 ·General Hospital

    E-POLY TIBIAL BEARINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PORTEX GENERAL ANESTHESIA CIRCUIT

    FDA Adverse Event
    Malfunction ·Product code CAG·March 7, 2019

    E-POLY TIBIAL BEARINGS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 27, 2011

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·June 20, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 17, 2014

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·June 14, 2018

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019