BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    BLACKSTAR(TM) STAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SYSTEMATE CALCIUM (EPOS APPLICATION) #65409

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THREE WHEEL SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 6, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2014

    ACUITY

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·January 4, 2011

    BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSO·July 15, 2022

    BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSO·March 29, 2022

    PLATE CHOCO GC AGAR W/ISOVITALEX 90MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSO·June 1, 2021

    EVOLUT FX DCS

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NPT·November 10, 2025

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Enforcement
    Class III ·Ongoing·Alcon Research LLC·November 27, 2024

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code OJK·October 15, 2024

    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