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

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    MODEL DGH 6000 SCANMATE A

    FDA 510(k)
    FDA Class 2 ·Radiology

    UBIT-IR300 INFRARED SPECTROMETRY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PUMP TUBING WITH X-COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    SWIFT-LOCK ANCHOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·January 23, 2018

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013

    ENSEAL G2 ARTICULATING

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·September 16, 2014

    ADMIRAL XTREME PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·INVATEC INNOVATIVE TECHNOLOGIES SPA.·Product code DQY·April 19, 2011

    SMALL ELECTRIC DRIVE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    DISP. IMA/ENT 3/4 NEEDLE ELECTRODE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code HGI·July 11, 2017

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    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