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

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    UNITEST AMYLASE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515203532·Curette Excavator, SE, 2.0mm cup, 5", without hole

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111298370·JACKSON TRACH TUBE #2-4 PIECE

    SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SterilContainer S System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VERSADIAL HEAD IMPACTOR

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code HWA·April 30, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012

    ROTALINK? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MCX·May 19, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021