BEUDAMED
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    AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099860·MN 2ND BI BD KT N/L R/L 176

    iQ200

    FDA UDI
    BECKMAN COULTER IRELAND INC.·10837461001300·"iQ200 Select 2008 Tested;800-3935 iQ®200 Selec...

    FacetFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361020110·Facet Screw Assy, SOTW, 6.0 x 45mm

    SURGI-VISION URETHRAL COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    LINER: MPACT HOODED PE HC LINER Ø36/F

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·April 6, 2022

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 17, 2014

    BONE SPREADER 7MM BEAK WIDTH

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·February 28, 2013

    OT PING METER

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

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·February 27, 2008

    VERCISE GENUS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·February 6, 2026

    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 Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·May 24, 2023

    iQ200 Series Urine Microscopy Analyzer- All part numbers

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·May 20, 2020

    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·February 5, 2020

    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

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

    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