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

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    HIGH FLOW INSUFFLATION UNIT UHI-4

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PT2 VARIAN PROTON THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012

    INSERT-HANDLE F/PFN+PFNA

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 7, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 26MM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·September 23, 2014

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 1, 2011

    Performer

    FDA UDI
    COOK INCORPORATED·00827002132788·Check-Flo Performer, Introducer

    Performer

    FDA UDI
    COOK INCORPORATED·00827002092068·Check-Flo Performer, Introducer

    TRULIANT TIB IMP CR INS STD SZ 5, 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 18, 2023

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025