BEUDAMED
    11 results · 37ms · Sources: EU EUDAMED, US FDA

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    IG_PLEX CELIAC DGP PANEL

    FDA 510(k)
    FDA Class 2 ·Immunology

    REMINGTON I-LIGHT HAIR REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·SHASER INC·Product code ONF·May 21, 2021

    INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D

    FDA 510(k)
    FDA Class 1 ·Dental

    OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500

    FDA 510(k)
    FDA Class 2 ·Radiology

    BDRV CANN SCW SS P/T DIA4.5X60 MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017

    BDRV CANN SCW SS P/T DIA4.5X52 MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·May 31, 2013

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·June 15, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·September 3, 2008

    SMARTPHONE IOS APP: PUMP CONNECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·July 16, 2025

    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