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

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    X-RAY TV SYSTEM SONIAL VISION G4

    FDA 510(k)
    FDA Class 2 ·Radiology

    LMA

    FDA UDI
    TELEFLEX INCORPORATED·05060112310478·LMA Fastrach™ ETT 7.5mm

    LMA

    FDA UDI
    TELEFLEX INCORPORATED·15060112318785·LMA Fastrach™ ETT 7.5mm

    Biogel

    FDA UDI
    Bosma Enterprises·10818634023602·Biogel Optifit Ortho Surgical 7.5 - 40 Pair/Box

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019315057274·

    EMBRYO VIEWER SOFTWARE

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

    ELECSYS INSULIN CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Widex

    FDA UDI
    Widex A/S·05706069812428·Widex EVOKE E-PA (Lime green ) 330, RC coil

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 5, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·September 6, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 5, 2019

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014

    RESTYLANE L, RESTYLANE LIDOCAINE

    FDA Adverse Event
    Injury ·Q-MED AB·Product code LMH·May 21, 2013

    CAPSUREFIX NOVUS

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

    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 7, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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