BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Rotatable Snares, Non-Rotatable Snares

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

    TRULIGHT 5520 AND TRULIGHT 5320

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

    SYNTHES (USA) 2.0MM TITANIUM T-PLATE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD CONVENTIONAL NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY·Product code FMI·October 9, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·July 22, 2011

    XCEL DILATING TIP TROCAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 17, 2013

    ACRYSOF TORIC

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MJP·September 18, 2008

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019

    PEDICLE SCREW 6X45

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019

    Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11061640 SOMATOM go.Top Model 11061648 NA* SOMATOM X.cite Model 11330001 SOMATOME X.ceed Model 11330002 SOMATOM go.Sim Model 11061660 NA* SOMATOM go.Open Pro Model 11061670 NAEOTOM Alpha Model 11330003

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 1, 2023

    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