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

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    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205004208·Luna Opal R Mini .022 UL1 (+12°T +5°A)

    BD Difco™ QC Antigen Salmonella O Group A

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902213017·BD Difco™ QC Antigen Salmonella O Group A, 1 mL

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946024260·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946071967·X SERIES, MONITOR/DEFIBRILLATOR, HOSPITAL, 3/5 ...

    MST/Dewey .9mm A1 Bent Ph Tip 30deg

    FDA UDI
    MICROSURGICAL TECHNOLOGY, INC.·00844685000289·

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517085716·

    XPRESSWAY RX CATHETER (6F LD-VERISON)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    X100 with Full Field Peripheral Blood Smear (PBS) Application

    FDA 510(k)
    FDA Class 2 ·Hematology

    CASPIAN Spinal System

    FDA UDI
    VB Spine LLC·10888857242586·Reduction Jack Rotation Tube, w/Driver

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    ITOTAL IDENTITY IMPACTOR HANDLE

    FDA Adverse Event
    Injury ·CONFORMIS, INC.·Product code LXH·May 5, 2023

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·April 9, 2022

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·September 27, 2018

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 3, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FMJ·July 1, 2013

    IMPACTOR HANDLE REUSABLE INSTRUMENT

    FDA Adverse Event
    Malfunction ·CONFORMIS·Product code LXH·April 24, 2024

    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

    FDA Enforcement
    Class II ·Ongoing·Conformis, Inc.·February 22, 2023

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Tenex Health Inc·May 14, 2014