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

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    UNIVERSA PERCULTANEOUS DRAINAGE CATHETER

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

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOB·May 2, 2018

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506088599·CYSTOSCOPY OPTICAL INSTRUMENT STONE GRASPING F...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003636·TR BSSO Plate, 10mm

    Merit® Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450499719·

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L14008528K0·Square Driver

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L14008523K0·Square Driver

    PERSONAL WARMING LUBRICANT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VANTAGE VIEW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 26, 2024

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 12, 2025

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 3, 2025

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 29, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

    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

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024