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

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    MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707045876·ADAMS CLASPS SIZE 7MM

    Orthopedic manual surgical instrument

    FDA UDI
    BAUI BIOTECH CO. LTD.·04712899253110·Torque Wrench 12N-m

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101070·Distractor, Smooth Paddle, Lordotic, 7mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101070·Distractor, Smooth Paddle, 7mm

    R STENT BILIARY ENDOPROSTHESIS

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

    SMARTEPIL

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

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 20, 2013

    ACCU-CHEK ACTIVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 10, 2008

    FINELINE II

    FDA Adverse Event
    Death ·CPI - DEL CARIBE·Product code NVN·April 15, 2011

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·August 23, 2019

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·August 23, 2019

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology