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

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    CLEARCANVAS RIS / PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    Smith & Nephew, Inc.·03596010035004·HIBBS OSTEOTOME CURVED 9.5MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776407841·Gorney Rake Retractor with Spring

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332601·IN-OVATION® C Roncone 022 UL/3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332101·IN-OVATION® C Base Rx 022 UL/3-3 CS HK

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK

    NA

    FDA UDI
    STERILMED, INC.·10888551035002·SAW BLADE OSCILLATING WITH ARBOR INTRA ORAL

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306802805·Gorney Rake Retractor, Spring Neck, 4 Sharp Pro...

    WAKO IMMUNOASSAY CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMC-20 PORTABLE DENTAL CART MODEL AMC-20

    FDA 510(k)
    FDA Class 1 ·Dental

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807110332901·MYSTIQUE® MB Roncone 022/LR3 -3T 7A 2M

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807110332001·MYSTIQUE® MB Base Rx 022/LR3 -11T 7A 2M

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807110332911·MYSTIQUE® MB Roncone 022/LR3 -3T 7A 2M HK

    SMARTSET GHV GENTAMICIN 40G

    FDA Adverse Event
    Injury ·DEPUY CMW - 9610921·Product code LOD·October 17, 2019

    OT VERIO IQ METER

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

    CORDLESS DRIVER 3

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·September 23, 2014

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 20, 2011

    UNKNOWN OPTEASE VENA CAVA FILTER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DTK·January 26, 2012

    UNKNOWN OPTEASE VENA CAVA FILTER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DTK·January 26, 2012

    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