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

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    PHOT-X IIS MODEL 505

    FDA 510(k)
    FDA Class 2 ·Dental

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 8, 2012

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·December 12, 2011

    BIOPORE BALLOON DILATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    K-WIRE, RECON 3.2X400 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 29, 2011

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 20, 2013

    INTERSTIM

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·December 13, 2011

    KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018

    530G INSULIN PUMP MMT-751NAL

    FDA Adverse Event
    MEDTRONIC MINIMED·Product code OZO·October 3, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MPRI·Product code DTB·June 3, 2013

    PFC C/R FEM CEM LFT SZ5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 22, 2011

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·February 6, 2018

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021