BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER

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

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950008803·ACE EXTENSION TUBE 20" STER 3CC VOLUME L/F 100/CA

    Latitude™ EV

    FDA UDI
    TORNIER, INC.·00846832002481·Ulnar Stem - Coated

    OPTIMUM

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975031488·

    Invotec Silicone Sheeting

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501021253·Invotec Silicone Sheeting 12 X 12 X 0.020"

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795133335·20mm End Cap, Ti

    K034020

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (BASD)·Product code LJS·November 16, 2007

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310300200·Talar Osteotmy Guide, 30mm x 20mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710300300200·Tibial Osteotmy Guide, 30mm x 20mm

    CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO ISOBAR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LAP BAND

    FDA Adverse Event
    Malfunction ·ALLERGAN INC.·Product code LTI·March 28, 2013

    WINGSPAN¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code NJE·March 25, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·April 14, 2008

    PLUM LS PRIM. 225 CM CLAVE PORT DISTA

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

    Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·September 25, 2019

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 22, 2019

    Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 26, 2018

    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