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

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    REL-K ARTIFICAL LIMB PROSTHESIS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973271·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172971178·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172972991·

    KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENILE CONSTRICTOR RING

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

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973646·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973561·

    Widex

    FDA UDI
    Widex A/S·05706069727050·Widex EVOKE E-PA (Silver Grey S-220 ) RC coil

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·May 9, 2013

    HUDSON CONCHA NEPTUNE

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code BTT·August 18, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 25, 2011

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code MMY·March 17, 2014

    UNKNOWN SOLITAIRE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·December 23, 2024

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code DXE·October 23, 2012

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORP.·Product code DXE·December 21, 2012

    THROMBUSTER II

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code DXE·January 16, 2019

    UNKNOWN SOLITAIRE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·December 23, 2024

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024