BEUDAMED
    23 results · 29ms · Sources: EU EUDAMED, US FDA

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    BD MAX Extended Enteric Bacterial Panel, BD MAX System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022

    INTEGRAL X-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304182424·

    Walgreens

    FDA UDI
    WALGREEN CO.·00049022633162·MAXIPAD 4CHANNEL SUPER UNSCENTED 24CNT

    Denovo Preformed Matrix Band

    FDA UDI
    Denovo Dental, Inc.·00810059290884·Denovo Preformed Matrix Band - Pediatric 3/16, ...

    INTEGRAL X-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304182134·

    PROSTHETIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PHILIPS SONICARE

    FDA Adverse Event
    Malfunction ·PHILIPS ORAL HEALTHCARE·Product code JEQ·July 24, 2018

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018

    SEE H-10

    FDA Adverse Event
    STAAR SURGICAL COMPANY·Product code HQL·June 14, 2013

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·July 20, 2011

    COPILOT VL

    FDA Adverse Event
    Injury ·MAGAW MEDICAL·Product code CCW·September 25, 2014

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 18, 2019

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·December 23, 2020

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·June 17, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·January 23, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 16, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·October 8, 2019

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017