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

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    HOPPENSTEIN MICROSURGICAL SPINAL INSTRU

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

    TOUAREG OS DENTAL IMPLANT

    FDA Adverse Event
    Injury ·ADIN DENTAL IMPLANT SYSTEMS LTD·Product code DZE·June 3, 2024

    SMD Sr90-1 Radionuclide Brachytherapy Source

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHO-THERM INFRARED SENSOR

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    UNKNOWN PE INLAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KXA·June 2, 2014

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 21, 2012

    ARTICUL/EZE BALL 28+5 BR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·September 10, 2010

    HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems.

    FDA Recall
    Terminated ·EUROTROL INC·Product code GGM·October 18, 2018

    HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems

    FDA Recall
    Terminated ·EUROTROL INC·Product code GGM·October 18, 2018

    SmartPath to dStream for 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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