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

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    QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Bernafon

    FDA UDI
    Bernafon AG·05711584021880·MD3 CP, VC PS DB MONDO 3

    BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIQUICHEK URINE CHEMISTRY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 8, 2018

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 2, 2023

    ANIMAS INSULIN INFUSION PUMP

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

    LIGASURE ADVANCE PISTOL GRIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·July 28, 2014

    BRYAN CERVICAL DISC SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MJO·June 11, 2011

    VERSE POLY DRIVER SHAFT NAV

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

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

    Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·January 15, 2014

    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