BEUDAMED
    20 results · 29ms · Sources: EU EUDAMED, US FDA

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    FATHOM (TM) 14 STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111398735·NURSES BAND SCISS ORANGE 5 1/2

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089476466·

    INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    EASY CONTROL MICRO INSERTER, MODEL ON385

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TOMCAT CUTTER

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY·Product code GFF·May 9, 2013

    UNKNOWN DEPUY MBT TRAY SZ2.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 13, 2011

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    ULTRATHANE SUPRAPUBIC CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOB·August 23, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·July 21, 2021

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021