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

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    IDS-ISYS IFG-I CONTROL SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD111104120·Wide Punch, Low Profile, Straight Jaw, Large, S...

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973100492·Poly Insert CR, Size 4, 12mm

    FLEXIBLE ENDOSCOPIC SCISSORS

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

    BIOLOX DELTA CERAMIC FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DELTA CER HEAD 12/14 28MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·September 8, 2021

    RECLAIM PRX BDY CONE 20X75

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code KWA·September 8, 2021

    OT VERIO TEST STRIPS

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

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 16, 2014

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 25, 2011

    OASYS

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code LRK·April 28, 2022

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017

    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

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015