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

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    Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant

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

    Oticon

    FDA UDI
    Oticon A/S·05707131281760·H15V2, BTE 13 WL 100 DBL

    FRAXEL SR LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BONEOPTIMIZER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 7, 2021

    AMISTEM H CEMENTLESS STEM SIZE 1 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 2, 2015

    FLEXTEND

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code DTB·October 8, 2014

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE CLEVELAND STREET·Product code ILJ·June 6, 2013

    TOTAL ASR FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 29, 2011

    AMISTEM H, HA COATED STEM SIZE 1 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 23, 2017

    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