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

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    JETSTREAM

    FDA 510(k)
    FDA Class 2 ·Dental

    Diamond D

    FDA UDI
    Keystone Industries·H66810142521·Diamond D HIPA, 5 lb, Original Pwd

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142120·Trial, TLIF, 32L OB CRV 7Deg, 12mm

    EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGNUM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·BIOFORM MEDICAL, INC.·Product code LMH·April 9, 2010

    COMPLETE

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 6, 2013

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 12, 2008

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·April 27, 2015

    Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.

    FDA Enforcement
    Class II ·Terminated·Parks Medical Electronics, Inc·December 5, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022