BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    BBLCHROMAGAR MRSA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776178796·Goodwin Sound Open Tip fr

    Bard® Goodwin Sound

    FDA UDI
    C. R. Bard, Inc.·00801741047220·Bard Goodwin Sound Open Tip 12 Fr.

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code PMP·November 20, 2023

    IRIS RETRACTING PHACOEMULSIFICATION SLEEVE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAROTID GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Octane Straight PC

    FDA UDI
    Choice Spine, LP·10885862278456·

    Octane Straight

    FDA UDI
    Choice Spine, LP·10885862236043·

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code PMP·July 3, 2024

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·April 9, 2013

    3.5FR P.U.R. UMBIL CATH X10

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FOS·March 30, 2011

    VITALITY DS

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018