BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Laparoscopic Handles with peek Insulation

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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490542616·CAGE ADAPTER INNER TRAY

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120502·Guidewire 1.2x150mm Dbl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120519·Guidewire 1.2x150mm Sgl Trocar

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE

    PRELUDE III TONGUE SUSPENSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ELI 230 ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RUNTHROUGH NS

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 7, 2015

    MILLENNIUM VENTILATOR

    FDA Adverse Event
    Malfunction ·SECHRIST INDUSTRIES, INC.·Product code CBK·July 22, 2016

    MILLENNIUM VENTILATOR

    FDA Adverse Event
    Malfunction ·SECHRIST INDUSTRIES, INC.·Product code CBK·December 17, 2015

    UNKNOWN NATURAL KNEE II TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·May 30, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    LUMAX 340 DR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK GMBH AND CO.·Product code MRM·August 29, 2008

    VERSAFITCUP DM HC LINER 54/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code MEH·July 9, 2015

    AIRVO2 HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 2015

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·October 2, 2015

    RUNTHROUGH NS

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 7, 2015

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·August 8, 2012