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

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    TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694002585·37 x 50mm Mesh Plate

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319703236·Tissue Forceps 5" (12.5cm), 1x2 teeth

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036031176·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450022849·

    ZS-100IR

    FDA UDI
    SHIMADZU CORPORATION·04540217013562·

    DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYCARE LATEX EXAMINATION GLOVE, POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Trilogy®

    FDA UDI
    Zimmer, Inc.·00889024116641·

    Trilogy®

    FDA UDI
    Zimmer, Inc.·00889024360983·

    Trilogy®

    FDA UDI
    Zimmer, Inc.·00889024637450·

    Trilogy®

    FDA UDI
    Zimmer, Inc.·00889024637467·

    IMPELLA CP

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code OZD·August 21, 2024

    AUTOMATED IMPELLA CONTROLLER

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code OZD·November 8, 2024

    ARTICULEZE M HEAD 36MM +12

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 20, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 25, 2014

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 26, 2011

    AUTOMATED IMPELLA CONTROLLER

    FDA Adverse Event
    Death ·ABIOMED, INC.·Product code OZD·August 20, 2024

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012