BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    HX-461

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SurgyCut

    FDA UDI
    U.S. SURGITECH INC.·00810014632605·SurgyCut Straight Blade Hand Control Electrode,...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319752890·Laparoscopic Monopolar Electrode 5mm w/o Suctio...

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017992·Wide Jaw Punch large 15 degree up milled 3.5mm ...

    FM-02 BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SLEEPRIGHT

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code MJN·June 10, 2011

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 15, 2008

    GALAXY G3 MINI 1.5MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 24, 2020

    GALAXY G3 MINI 2.5MM X 4.5CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 29, 2020

    MICRUSFRAME10 6MM X 26CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·July 14, 2020

    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

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023