BEUDAMED
    27 results · 34ms · Sources: EU EUDAMED, US FDA

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    VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fluid Retention Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM

    Orthopaedic Surgical Instruments

    FDA UDI
    CITIEFFE SRL·08056711921181·

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365106392·

    COVERIS

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030CS1021350·Trial,14mm x 16mm Lordotic 7°, 9mm

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021350·SPIRA®-A Integrated,Trial, 30x34mm, 20° Lordoti...

    Fixed Reference Anterior ROT Guide 5 deg

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215056438·

    POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SLEEPSTRIP DISPOSABLE APNEA SCREENER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MENTOR MEMORYSHAPE BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·September 16, 2021

    MENTOR MEMORYSHAPE BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·September 16, 2021

    GMK-REVISION TIBIAL WEDGE SIZE 4/10MM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2013

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code MZW·September 19, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011

    SLEEK OTW PTA CATHETER

    FDA Adverse Event
    Injury ·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023

    INCEPTIV

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·March 19, 2025

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·September 29, 2006

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·March 9, 2016

    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