BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HONIGUM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNKNOWN FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·April 22, 2013

    ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·July 9, 2008

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 15, 2011

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014

    PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).

    FDA Enforcement
    Class II ·Terminated·bioMerieux, Inc.·April 29, 2020

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024