BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    BRIVANT GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862268518·

    Truliant CC

    FDA UDI
    Exactech, Inc.·10885862613189·TRULIANT POST. AUG. BLOCK SIZE 5, 5MM

    EBI DYNAFIX VS OSTEOTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMAGE X-70 PLUS DENTAL X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    LOGIC PSC TIB INS SZ 5 17MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 14, 2023

    OPTETRAK LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 7, 2023

    THREE PEG PATELLA 38MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 22, 2024

    TRU CC TIB INSERT SIZE 5, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 24, 2025

    TRULIANT TIB FIT TRAY CEM SZ 5F / 5T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 21, 2024

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 16, 2013

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·June 12, 2008

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·April 6, 2011

    BASE PLATE 15 MM POST LENGTH STERILE PRODUCT DO NOT RESTERILIZE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWT·August 25, 2017

    HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWT·August 25, 2017

    LOGIC CC TIB INSERT SIZE 5, 17MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 2, 2024

    GLENOSPHERE 36 MM DIAMETER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWT·August 25, 2017

    CC TIBIAL INSERT SZ 5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 7, 2023

    OPTETRAK LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 15, 2023

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013