BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    PrisMax Control Unit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NATRELLE Saline-Filled Breast Implants

    FDA UDI
    Allergan, Inc.·10888628000728·STYLE 163 530CC Full Projection BIOCELL |textur...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111285325·TC MAYO DISS SCIS STR B/B 5.5"

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108338·BARRAQUER NEEDLE HOLDER CURVED

    ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPIRODOC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 10, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 10, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013

    BLADDER MESH

    FDA Adverse Event
    Malfunction ·Product code FTL·July 7, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code ELC·April 29, 2020

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code ELC·May 31, 2023

    EQ REV GLENOID PLATE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·December 13, 2022

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020