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

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    NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526173668·PROTECT.EPI ELBOW SUPPORT GRAY VI

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321308060·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311308060·

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857562387·Lordotic Trial Size 22x50x9 mm, 8°

    BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

    FDA 510(k)
    FDA Class 2 ·Dental

    DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·January 22, 2014

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 12, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 24, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CHANDLER·Product code KDJ·September 30, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 12, 2014

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·June 25, 2014

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·January 27, 2014

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 12, 2014

    Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000).

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code JDR·June 2, 2006

    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