BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Motif Aura Glow breast pump (Model Motif Aura Glow)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517631855·CoRoent Ant TLIF Ti, 15x10x36mm 15°

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 5, 2023

    BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202

    FDA 510(k)
    FDA Class 2 ·Hematology

    Cloud9 System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    FDA Adverse Event
    Injury ·THORATEC CORP·Product code DSQ·December 3, 2008

    LOCKING SCREW, T10, 3.5X16MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code HRS·July 26, 2013

    NEEDLE

    FDA Adverse Event
    Injury ·HTL-STREFA, INC.·Product code FMI·September 23, 2019

    XVWEB

    FDA Adverse Event
    Injury ·PLANET DDS·Product code LLZ·March 13, 2025

    SECOND OPINION

    FDA Adverse Event
    Injury ·PEARL INC.·Product code MYN·March 13, 2025

    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 REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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