BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    VISUALIF CHALLENGING ACCESS PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SENSEI X ROBOTIC CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENVOY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·November 16, 2017

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 21, 2013

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXE·June 13, 2011

    FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYG·August 14, 2008

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 26, 2013

    S-ROM M HEAD 36MM +3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 26, 2013

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 26, 2013

    S-ROM M HEAD 36MM +6

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 26, 2013

    PINNACLE 100 ACET CUP 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 2, 2013

    PINNACLE 100 ACET CUP 56MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 2, 2013

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024