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

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    VirtuoSaph Plus Endoscopic Vessel Harvesting System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481137884·LOCATOR R-Tx Attachment System for Hiossen Impl...

    Diamond Burr

    FDA UDI
    ELLIQUENCE, LLC·00846338002756·

    AESCULAP- MEITHKE SHUNT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MISSION COMPLETE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 3, 2023

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LGD·January 28, 2011

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·June 10, 2013

    HUDSON NEONATAL VENTILATOR CIRCUIT W/18 IN R

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·June 2, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    HAMILTON MEDICAL AG

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·March 10, 2024

    LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018