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

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    ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M-Flex®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020029·Blue Silicone Tungsten Maloney Esophageal Dilat...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450194294·

    INVENDO C20 COLONOSCOPY SYSTEM

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

    BREAST BOLSTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PIPELINE FLEX

    FDA Adverse Event
    Injury ·MEDTRONIC COVIDIEN·Product code OUT·November 16, 2016

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022

    TOTAL ASR FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·May 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 10, 2011

    AED PRO

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

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code GWO·April 16, 2018

    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