BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    ACCUCATH MIDLINE CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925017085·RICHARDS FLUOROPLASTIC BUCKET HANDLE PROSTHESIS...

    MAXIM VI KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304205512·

    VESSEL GUARDIAN

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

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

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·September 7, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    BATHLIFT BLISS RECLINER US AB

    FDA Adverse Event
    Malfunction ·HANDICARE·Product code FSA·May 23, 2013

    PENUMBRA COIL 400 - PUSHER ASSEMBLY

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code HCG·May 26, 2011

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026