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

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    MICROTHIN-D1 (MOD. 0620)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    NUPRO® Prophylaxis Paste with Fluoride

    FDA UDI
    DENTSPLY INTERNATIONAL INC.·D0038011221·NUPRO® Prophy Paste, Mint, Medium, 340g Jar, Si...

    ACUMED

    FDA UDI
    Acumed LLC·10806378046773·Small Farabeuf Pelvic Forceps

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016036·ROD CONNECTOR, PARALLEL CLOSED 12mm OFFSET, Ø 4...

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016050·ROD CONNECTOR, PARALLEL CLOSED 16mm OFFSET, Ø 4...

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016029·ROD CONNECTOR, PARALLEL CLOSED 10mm OFFSET, Ø 4...

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016043·ROD CONNECTOR, PARALLEL CLOSED 14mm OFFSET, Ø 4...

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016067·ROD CONNECTOR, PARALLEL CLOSED 18mm OFFSET, Ø 4...

    PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FUSION MEDICAL CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 29, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 8, 2014

    PUMP IN STYLE (ITEM # UNK)

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·October 17, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007

    VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

    FDA Recall
    Terminated ·SynCardia Systems Inc.·Product code LOZ·August 6, 2015

    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

    FDA Recall
    Terminated ·SynCardia Systems Inc.·Product code LOZ·October 21, 2016

    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    FDA Recall
    Open, Classified ·SynCardia Systems LLC·Product code LOZ·November 2, 2022

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024