BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    COCHLEAR BAHA 4 SOUND PROCESSOR

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

    HHM

    FDA UDI
    Oticon A/S·05707131256614·H150, MINIBTE 312 WL 85 CNB HHM

    PEDICLE SCREW MONOAXIAL SCREW 5X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019

    QUADRA BLOC TENS PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMP TM 4.7MM MTX FULL, 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 27, 2024

    BD ULTRA-FINE¿ MICRO PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 24, 2022

    BD ULTRA-FINE¿ MICRO PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 24, 2022

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·May 29, 2013

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·October 1, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 17, 2011

    MUST PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2017

    IMP TM 4.7MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

    IMP TM 6.0MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 29, 2023

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·February 5, 2014

    PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·July 4, 2018

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·January 6, 2014

    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