BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Scissors

    FDA UDI
    KATENA PRODUCTS, INC.·00841668105344·TIBOLT PUNCTAL SCISSORS

    Integral Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 2, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·November 21, 2012

    S-ROM*SCREW,6.5MM DIA,35MM LG

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 14, 2015

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

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

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021