BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    TRILOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481119538·LOCATOR F-Tx Abutment For Large Internal Conica...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481113024·LOCATOR R-Tx Abutment for Large Internal Conica...

    DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DORNIR LC-1 CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVISOR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

    ADVISOR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

    AVIATOR PLUS PTA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code LIT·April 22, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 14, 2011

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    FDA Adverse Event
    Other ·EV3 INC.·Product code FGE·July 2, 2008

    Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

    FDA Enforcement
    Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

    Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Endoscopy Division·Product code FXM·February 19, 2004

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022