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

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    MiVu™ Esophageal Endo Cap

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464021543·CORAL 9 FW 4.1

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113660·CYSTOTOME STRAIGHT 25GA

    Cooley Ring-Bulldog Clamp 13cm straight jaw

    FDA UDI
    Geister Medizintechnik GmbH·04057034060773·Cooley Ring-Bulldog Clamp 13cm straig...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776198220·Bergstrom SMBN Skel Muscle Biop

    PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WORRY-REMOVER IRRIGATOR

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    OPHTHALMIC FEMTOSECOND LASER

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021

    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·January 31, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 11, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·July 16, 2013

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

    FDA Recall
    Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 16, 2021

    CATALYS PRECISION LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 8, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021