BEUDAMED
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    KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM

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

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964022683·The ENDO CARRY-ON Procedure Kit contains all of...

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085022581·Giemsa (Malaria) Stain Buffer 5x250ml

    Optetrak

    FDA UDI
    Exactech, Inc.·10885862630360·ARC Guide Sliding Stylus

    iQ200

    FDA UDI
    BECKMAN COULTER IRELAND INC.·10837461001256·"iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Spri...

    FacetFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361020073·Facet Screw Assy, SOTW, 6.0 x 25mm

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365106156·

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 21, 2014

    FLO ASSISTANT, MODEL 4-250-00

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

    WUJIN #3 TIBIAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·October 20, 2025

    2520274-2013-10933

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code MNI·February 28, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 1, 2011

    GE OEC FLUOROSTAR

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 27, 2008

    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KQO·March 2, 2018

    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 18, 2018

    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·January 31, 2024

    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023