BEUDAMED
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    HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII

    FDA 510(k)
    FDA Class 2 ·Immunology

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780379171·Integra® Jarit® Bakes Common Duct Dilator, 8-1/...

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925014510·SCHUK FLPL-SS WIRE PIST

    GOBEN

    FDA UDI
    HUZHOU JUNDA INDUSTRY CO., LTD.·06979032640079·Surgical Laparotomy Sponges, Prewashed,Soft Pac...

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989044041·CROWN-PERM LR 5 1ST BICUSPID SST PK/5

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981208691·Trial, 11mm x 40mm x 10mm, 15 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981193584·Interbody, 11mm x 40mm x 10mm, 15 deg

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981201579·Interbody, 11mm x 40mm x 10mm, 15 deg

    MICROFRANCE® INSTRUMENT

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·April 17, 2015

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68111001401050·5.5mm x 105mm MIS Straight Rod

    MICROFRANCE® INSTRUMENT

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·January 8, 2015

    YUE PFONG SAFETY SYRINGE (3ML)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROXIMATE INTRALUMINAL CIRCULAR STAPLER - 29MM

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GAG·June 4, 2003

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 29, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·August 28, 2008

    BD INSULIN PEN NEEDLE

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

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2017

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017