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

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    GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827943·ACHIMED ACHILLES SUPP BLACK VI

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113324·PS Insert, Size 5 x 16mm

    CARE IFC PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    LONG LIFE PADTM

    FDA 510(k)
    FDA Class 2 ·Neurology

    TARGETING ARM T2 PROX. HUM.

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA GMBH·Product code LXH·August 7, 2012

    ULTRASONIC IMAGING CATHETER - CORONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·January 17, 2013

    2.1MM #703 TAPERED BUR

    FDA Adverse Event
    Injury ·OSTEOMED LP·Product code EJL·December 4, 2010

    ZEPHYR DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015