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

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    ENDOSCOPIC APPLICATOR

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

    Bard® Urethral Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741029936·Bard® Tiemann Model Urethral Catheter Coude Tip

    36M - Southside Electrical Coop - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588206080·36M - Southside Electrical Coop - Metal

    ZAVATION F3D-Z CIF

    FDA UDI
    Zavation LLC·00197157020460·F3D-Z CIF 14mmx16mmx8mm -6 deg

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450408896·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383505673·Gutta Percha Points is used to root canal filin...

    Zavation

    FDA UDI
    Zavation LLC·00842166188129·Custom PLIF SIZER

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857551275·Offset Blade Right Size 110 mm

    KING SEPTEMS

    FDA Adverse Event
    Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

    SECURMARK BIOPSY SITE MARKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PERMACOL 10X15 1.5MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

    3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/16MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·May 20, 2013

    CX/LX LIPASE (LIP)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CHI·June 10, 2011

    SENSORMEDICS

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 207, INC.·Product code LSZ·August 13, 2008

    13 CM TRICUT BLADE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ENT (JACKSONVILLE)·Product code HAW·July 23, 2015

    CURVED SINUS BURS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EQJ·June 2, 2014

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway

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

    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