BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO ALLOMATRIX CUSTOM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013

    FOTONA DUALIS, FOTONA DUALIS PLUS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VITALCARE FOLEY CATHETER

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

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code GWF·February 20, 2018

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 2, 2013

    NIM-ECLIPSE® PATIENT MODULE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 6, 2017

    PROBE SPK1004 SURGEON CONTROLLED

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·May 17, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 14, 2015

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    COMPUTER NOTEBOOK (INTERNATIONAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 5, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 16, 2013

    MAVERICK OVER-THE-WIRE PTCA CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code LOX·June 16, 2008

    CONTROLLER ECLC ECLIPSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014

    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    NIM-ECLIPSE PREAMPLIFIER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 7, 2021

    COMPUTER NOTEBOOK (INTERNATIONAL)

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·April 13, 2026

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015