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

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    DSG Connect Technology

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    7600 V MASK

    FDA UDI
    HANS RUDOLPH, INC.·00874750001385·SWIVEL PORT ASSY W/AAV 22MM ID

    SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNITY NETWORK ID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 16, 2008

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013

    IAB: 7.5 FR - 40 CC

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·August 3, 2011

    ONYX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·October 10, 2024

    ONYX

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·October 10, 2024

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·October 10, 2024

    INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 8, 2015

    VAXCEL PASV PICC

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LJS·January 22, 2008

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021