BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55

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

    Latitude™ EV

    FDA UDI
    TORNIER, INC.·00846832002856·Humeral Stem - Coated

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00699753461529·

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114106·LOCATOR R-Tx Abutment for 3.4mm External Hex Im...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange

    LATITUDE

    FDA Adverse Event
    Injury ·TORNIER INC.·Product code JDB·November 2, 2015

    LATITUDE

    FDA Adverse Event
    Injury ·TORNIER INC.·Product code JDB·November 2, 2015

    MODEL THERMO TEK QUICKCARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STEAM/EO RECORD CARD, MODEL CI 121

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LATITUDE

    FDA Adverse Event
    Injury ·TORNIER INC.·Product code JDB·November 2, 2015

    HEARTSTART MRX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011

    PRECISION

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·April 17, 2008

    PLUM LS PRIM. 225 CM CLAVE PORT DISTA

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018