BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets

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

    KaiBiLi Extended ViralTrans Saline

    FDA UDI
    Hangzhou Genesis Biodetection & Biocontrol Co., LTD.·16972698600538·5 mL with minitip flocked swab

    EVERSTICK ORTHO

    FDA 510(k)
    FDA Class 2 ·Dental

    MediExpand Cervical Expandable VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ESSURE

    FDA Adverse Event
    Malfunction ·CONCEPTUS, INC.·Product code HHS·October 23, 2008

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 23, 2011

    ASPHERE M SPEC 12/14 36 -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 11, 2013

    EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical Company·December 13, 2023

    Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

    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