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

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    E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTRELL

    FDA UDI
    Biosense Webster Inc·10846835023022·Mapping Catheter with TRUEref Technology

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925015395·SHEA TORP PROSTHESIS 0.85 MM SHAFT DIAMETER 5 M...

    Spacelabs Healthcare

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522120251·KIT,SINGLE BAND ACT ANT,W/OPS,PLEN ADC

    Xhibit

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522127021·KIT,SINGLE BAND ACT ANT,W/OPS,PLEN ADC

    HITACHI PRESTO

    FDA 510(k)
    FDA Class 2 ·Radiology

    AEDIS(TM)

    FDA 510(k)
    FDA Class 2 ·Dental

    LOGIC FEMORAL PS POR RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 10, 2025

    LOGIC CR FEMORAL POR, LEFT, SZ 3.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 11, 2024

    ALIGN R RETROPUBIC URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·May 24, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 3, 2014

    TALENT CONVERTER STENT GRAFT

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·June 22, 2011

    BD PEGASUS YEL 24GA X 0.75IN PRN

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 19, 2022

    ECLIPSE FILTER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 21, 2019

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 26, 2023

    NEEDLE 18X1-1/2 BLUNT FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·November 30, 2023

    NEEDLE 18X1-1/2 BLUNT FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·November 30, 2023

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014