BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    Clickfine AutoProtect Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169524279·TRIAL 2152514 MEDIUM 12 DEGREES 14MM

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014324·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 14

    INNESIS PEEK CERVICAL CAGE

    FDA UDI
    BK MEDITECH CO.,LTD.·08809763504723·Distraction Screw

    Symmetry Crile-Baby

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482035603·Symmetry® Forceps, Crile-Baby Artery, Curved, D...

    Symmetry Crile-Baby

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482172407·Symmetry® Forceps, Crile-Baby Artery, Curved, D...

    NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HNM Medical

    FDA UDI
    HNM STAINLESS, LLC.·00842962111222·CRILE BABY ARTERY FORCEPS, 5 1/2", DELICATE, CVD

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

    S-ICD SYSTEM

    FDA Adverse Event
    Injury ·CAMERON HEALTH·Product code NVY·June 17, 2014

    FC500? FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 7, 2013

    HUDSON OPTI-NEB COMPRESSOR

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAF·June 21, 2011

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·April 25, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·January 4, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·February 18, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·July 26, 2019

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025