BEUDAMED
    17 results · 29ms · 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.
    Filters Regulation: Us FDA ×

    IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    NA

    FDA UDI
    KEY SURGICAL, INC.·00849771048169·K-Wire and Steinmann Pin Dispensers, .035 inch...

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0170020·Driver Shaft, T10 Split Tip

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310020·Probe, 1.5 inch Ball, Steffee, Straight, Black

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 18, 2025

    ASI Disposable Stirrer Pipet

    FDA UDI
    ARLINGTON SCIENTIFIC, INC.·00816057021178·Disposable Pipet, 100/bag

    ASI Disposible Stirrer Pipet

    FDA UDI
    ARLINGTON SCIENTIFIC, INC.·00816057021185·Disposable Pipet, 500/bag

    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WAKO LIPASE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LINVATEC HALL

    FDA Adverse Event
    Malfunction ·LINVATEC·Product code HWE·July 29, 2003

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 22, 2013

    BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·April 19, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·August 19, 2011

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022