BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM

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

    WALLSTENT RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

    WALLSTENT? RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517235275·Armada Ti 3CO Osteotome, 6x6mm Cerv Box

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198734·AK3 Ultra Insert Trial Size 5, 10mm

    ENDOCLAMP AORTIC CATHETER

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code DXC·June 23, 2006

    DIAFIL & DIAFIL Capsule

    FDA 510(k)
    FDA Class 2 ·Dental

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PREMIER ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015

    ACUVUE CLEAR BRAND

    FDA Adverse Event
    Injury ·Product code LPM·March 4, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWP·August 8, 2014

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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