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

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    IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)

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

    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

    EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GPC Intramedullary Nailing Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·January 11, 2022

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 23, 2009

    LINER: MPACT FLAT PE HC LINER Ø36/E

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 7, 2024

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 23, 2009

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 7, 2008

    CURLIN INFUSION PAINSMART IOD IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MED DEVICES GROUP·Product code FRN·September 1, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·July 23, 2013

    SPRINT QUATTRO SECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·April 16, 2024

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·April 16, 2024

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code FTL·August 30, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2017

    COPAN WASP/COLIBRI

    FDA Adverse Event
    Other ·COPAN WASP·Product code QQV·July 25, 2024

    ATELLICA IM TOXOPLASMA IGG (TOXO G)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·May 8, 2020

    ATELLICA IM TOXOPLASMA IGG (TOXO G)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·June 25, 2020

    ATELLICA IM TOXOPLASMA IGG (TOXO G)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·May 8, 2020

    ATELLICA IM TOXOPLASMA IGG (TOXO G)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·May 8, 2020