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

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    OMNI-TIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D

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

    BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1911916-2018-00660

    FDA Adverse Event
    Malfunction ·November 13, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 28, 2011

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL QUEBEC, LP·Product code FNL·July 22, 2008

    PRESIDIO 10 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code DZI·May 19, 2015

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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