BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    Vortex Radial Spray Catheter

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

    24M - Nevada Energy - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal

    36M - Black & Veach - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal

    GALLAGER RETRACTOR 90 DEG

    FDA UDI
    W.H. Holden, Inc.·D9282011830·

    CS 9600

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO: OASYS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·May 22, 2018

    AEYE-DS RETINA SCREENING

    FDA Adverse Event
    Injury ·AEYE HEALTH INC.·Product code PIB·January 22, 2025

    SMOOTH STAPLE SCREW 1.6

    FDA Adverse Event
    Malfunction ·ATTACHMENTS INTL., INC.·Product code NDP·October 20, 2008

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 29, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    NIM® EMG

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code ETN·June 3, 2016

    UNK_ULTRACISION HARMONIC FOCUS

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 4, 2019

    INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code OVE·July 25, 2016

    DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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