BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    AFFIX II SPINOUS PROCESS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131257475·H150, BTE 13 WL 85 TC HHM

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102909·JAFFE-BECHERT MANIPULATOR ANG SHORT HNDL

    Vu cPOD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981039585·Implant Tapered 12x14x11mm (Non-Strut)

    MAMMOTOME ELITE BIOPSY SYSTEM

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

    JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·December 7, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 30, 2020

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·January 6, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·September 8, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·May 29, 2013

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·June 13, 2011

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·September 2, 2020

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 8, 2020

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 8, 2020

    THERMAGE CPT SYSTEM TIP

    FDA Adverse Event
    Injury ·SOLTA MEDICAL INC·Product code GEI·November 30, 2022

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012