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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    COLOSSEUM Mesh

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pre-Finisher

    FDA UDI
    TP ORTHODONTICS INC·00192029041703·Non-Extraction w/Seating Springs

    BLOOD MONITORING UNIT, MODEL BMU 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSERT, BIPOLAR FORCEPS

    FDA Adverse Event
    Malfunction ·RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code GEI·April 2, 2015

    ZILVER PTX 35 DRUG/ELUTING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIU·October 17, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·June 10, 2013

    ON-Q SS

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·March 10, 2011

    DELTAFILL18 10MM X 40CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020

    AQUAPAK 340 SW, 340ML 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

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023