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

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    CENTRIFICHEM URIC ACID

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517134943·Helix R Plate, 30mm 1-Level

    SPECTRUM

    FDA UDI
    Ortho Arch Company Inc·D9098001302·SPECTRUM TORQUING PLIER SET W/ WIDE KEY

    Cranial Blade Disposable low speed

    FDA UDI
    ACRA-CUT INC·00810607000392·Cranial Blade Disposable Low Speed 800-130 Pack...

    ACUMED

    FDA UDI
    Acumed LLC·10806378040139·Uni. Tray Gen. Congru Plate Insert Assy.

    Neotech Bridge®

    FDA UDI
    Neotech Products LLC·20812594012604·The Neotech Bridge is a breastfeeding assistanc...

    ADP,1,P800,S800,(2)1/4",N,TV,AUSTCO

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828118644·ADP,1,P800,S800,(2)1/4",N,TV,AUSTCO

    Electrode

    FDA UDI
    SOPRO-COMEG GmbH·04059082009735·

    Cranial Blade Disposable Low Speed

    FDA UDI
    ACRA-CUT INC·00810607000385·Cranial Blade Disposable Low Speed 800-130 Sing...

    OCCLUFAST CAD

    FDA 510(k)
    FDA Class 2 ·Dental

    HARDYDISK, NALIDIXIC ACID, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·December 12, 2018

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·May 8, 2014

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012

    LUPINE DRILL BIT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HTW·August 10, 2010

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NQO·January 5, 2021

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021