BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    VACORA VACUUM ASSISTED BIOPSY SYSTEM

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

    AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ANKYLOS

    FDA 510(k)
    FDA Class 2 ·Dental

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 11, 2014

    FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·July 21, 2008

    WHITE STAR HIGH SPEED VIT CUTTER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

    WHITE STAR HIGH SPEED VIT CUTTER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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