BEUDAMED
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    ENDOSCOPE REPROCESSOR OER-MINI

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

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017497·Hook Punch set down 3.5mm 45 degree left

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017480·Hook Punch set down 2.7mm 45 degree left

    ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    800 SERIES EASYNEB NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·March 30, 2016

    LOGIC TIBIA PS MOD INSRT SZ 2 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    THREE PEG PATELLA 32MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 28, 2024

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·June 10, 2011

    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