BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Oticon

    FDA UDI
    Oticon A/S·05707131256577·NERA, MINIBTE 312 WL 85 DBL

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694055321·1.6mm Orbital Floor Plate, Fan, .25mm Thick

    SYNAPSE 3D BASIC TOOLS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRESSURE WIRE SENSOR, MODELS 12004/12304

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAHN TAPERED IMPLANT Ø7.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 17, 2024

    HAHN TAPERED IMPLANT Ø7.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 3, 2025

    RELOAD FOR 60MM ECHELON

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·May 29, 2013

    MAXIMO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011

    OPEN-END FLEXI-TIP URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·February 6, 2020

    OPEN-END URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·February 7, 2020

    OPEN-END URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·December 5, 2019

    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