BEUDAMED
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    NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100165·KRATZ-BARRAQUER SPECULUM SMALL

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171029045·PESSARY, OVAL #2, W/SUPPORT, 2.25”

    WINDSURFER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FORTROSS BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code FGE·June 6, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·June 22, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026