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

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    REPROCESSED LINVATEC ARTHROSCOPIC BURS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648178467·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648179563·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648178450·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648179556·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648178474·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648178481·Omnilink Elite Vascular Balloon-Expandable Sten...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450307731·

    Kalitec

    FDA UDI
    Kalitec Direct LLC·B07319K0162300·Bone Funnel

    PURESPERM WASH

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

    Y-TZP POWDER AND PROCERA ALLZIRKON

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    Exactech, Inc.·10885862286253·2630 EXT REV STM NCK TRL

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIO·September 6, 2017

    PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code CAI·January 3, 2017

    ORTHOVISC

    FDA Adverse Event
    Other ·ANIKA THERAPEUTICS INC.·Product code MOZ·March 15, 2013

    UNKNOWN DEPUY 28MM +4 10D LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 24, 2011

    IDC - INTERLOCKING DETACHABLE COIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORK, LTD.·Product code HCG·March 10, 2008

    FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·November 7, 2018

    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·May 2, 2018

    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.

    FDA Recall
    Terminated ·BioFire Diagnostics, LLC·Product code PEN·March 14, 2018