BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    Salem Sump Dual Lumen Stomach Tube with Multi-functional Port

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

    Oticon

    FDA UDI
    Oticon A/S·05707131281579·NERA2, BTE 13 WL 100 STG

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100684·FISHKIND-CASTROVIEJO LID SPECULUM

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171028680·PESSARY, HODGE #8, W/O SUPPORT, 105mm

    SUCTION IRRIGATION ELECTRODES AND ADAPTERS

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

    FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 6, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

    NI

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWP·June 24, 2011

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 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