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

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    STERITEC GREEN CARD PACK BOWIE-DICK TEST

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Oticon

    FDA UDI
    Oticon A/S·05707131258243·H16, RITE 312 WL CNB

    HALSEY NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896022157·HALSEY NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP

    NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007

    FDA 510(k)
    FDA Class 2 ·Radiology

    OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB

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

    GENISTRONG

    FDA Adverse Event
    Malfunction ·GENICON·Product code GCJ·October 15, 2017

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code DXY·October 1, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·May 29, 2013

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·June 13, 2011

    CARDIOSAVE HYBRID

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020

    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

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·January 16, 2013

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015