BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    SOFIA INFLUENZA A+B FIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694033756·Low Profile 8 Hole Straight Plate

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311316060·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321316060·

    VACUTRON

    FDA UDI
    Allied Medical, LLC·00026072005743·CONTINUOUS SUCTION REGULATORS

    ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROMED PD-8K INSULATION DEFECT DETECTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COOK® CERVICAL RIPENING BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PFJ·July 18, 2016

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    COOK® CERVICAL RIPENING BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PFJ·July 19, 2016

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 1, 2014

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 17, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    MONOJECT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code NGT·February 12, 2018

    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

    Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code GKF·May 24, 2005

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018