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

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    SUREcore Plus Biopsy Instrument

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

    Zavation

    FDA UDI
    Zavation LLC·00842166132870·Ti3Z CIF 14mmx16mmx11mm -6 deg

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113362·PS Insert, Size 6 x 11mm

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676220611000·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676220611070·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676220611150·

    UNIVERSAL BONE PLATE III SYSTEM (UBP III)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONY PVM-2551MD OLED MONITOR

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

    TANDEM DIABETES 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8''

    FDA Adverse Event
    Malfunction ·EXELINT INTERNATIONAL, CO.·Product code FMF·December 20, 2024

    BARRIGEL INJECTABLE GEL

    FDA Adverse Event
    Malfunction ·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·June 24, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP·Product code MVK·July 15, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·November 3, 2014

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    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

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021