BEUDAMED
    19 results · 32ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    AUDIT MICROCV VITAMIN D LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295502470·DELTA XTEND Lateralized Glenosphere +4mm Eccent...

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295502487·DELTA XTEND Lateralized Glenosphere +4mm Eccent...

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295502456·DELTA XTEND Lateralized Glenosphere +4mm Standa...

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295502463·DELTA XTEND Lateralized Glenosphere +4mm Standa...

    Z-BOX

    FDA 510(k)
    FDA Class 2 ·Neurology

    REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 3, 2024

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 24, 2013

    PROMOTE RF CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 6, 2022

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 15, 2020

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·February 9, 2023

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·December 6, 2024

    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·March 19, 2014

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015