BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    SHARKCORE FINE NEEDLE BIOPSY SYSTEM

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

    Biomet® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304459892·

    HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ORTHOFIBER

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

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 7, 2019

    KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    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