BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    KENZ CARDY302 MAX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950018994·FORCEP IRIS DELICATE 1X2 TEETH STRAIGHT 4" 10CM

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704507898·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776170189·IN-E Hoff Towel Clamp, Non Perf, .

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746108464·DB BKT MINI MS UL LAT 022 T+18 A+6 R=0

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694002233·Mini 124mm x 124mm Mesh, Rigid

    Instrument

    FDA UDI
    BICON, LLC·00813110023957·Hex Screwdriver

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

    PASS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CYBERKNIFE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALLURA XPER FD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 2, 2026

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 8, 2013

    PRIDE

    FDA Adverse Event
    Injury ·PRIDE MOBILITY PRODUCTS CORPORATION·Product code INI·May 24, 2011

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Injury ·C.R. BARD, INC (BASD)·Product code KNT·August 1, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    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