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

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    SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

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

    Mini Unicycle™

    FDA UDI
    Ortho Organizers, Inc.·00190707056674·Mini Unicycle™ .120” Ligature Ties - Burgundy

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707009610·CALIBRA 1ST MOLAR BANDS n.UR 24

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319703977·DeBakey Atraumatic Tissue Forceps, 2.0mm wide t...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450194294·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450193938·

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327044393·Cruciate Retaining Tibial Insert

    PATIENTNET MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYTEL(R) APT MODEL: PWA-08-01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOLDEN COMFORTER

    FDA Adverse Event
    Malfunction ·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·March 16, 2021

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 7, 2013

    STEALTHSTATION® S7´

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 7, 2019

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 9, 2013

    M2A MAGNUM MODULAR HEAD 42MM HEAD DIAMETER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 10, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 14, 2008

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 17, 2013

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021