BEUDAMED
    15 results · 31ms · Sources: EU EUDAMED, US FDA

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    STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SAMARCO SPIDER PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 10, 2022

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 8, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 29, 2011

    N'VISION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·May 9, 2008

    LINEAR 7.5 FR. 40CC IAB

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 14, 2020

    NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 23, 2025

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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