BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    SMART-WELL INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Logical PX-Series

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215000592·

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GIVEN DIAGNOSTICS SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 19, 2025

    OSSEOSPEED TX 4.0S - 13 MM

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 9, 2024

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 21, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2011

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Other ·CYTYC SURGICAL PRODUCTS·Product code MNB·August 15, 2008

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 25, 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