BEUDAMED
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    CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102978·CAMLOG® Screw-Line-compatible 3.8mm Straight Mu...

    iQ200

    FDA UDI
    BECKMAN COULTER IRELAND INC.·10837461001355·"iQ200 Elite 2008 Tested; 800-3934 iQ®200 Elite...

    ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RANDOX CALCIUM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    iQ200

    FDA UDI
    BECKMAN COULTER IRELAND INC.·10837461001317·"iQ200 Select 2008 Instrument; 800-7190 IRICELL...

    SALINE BREAST IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE, LLC·Product code FWM·February 12, 2020

    DEXTRUS 4137

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·February 13, 2013

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·March 1, 2011

    BAXTER

    FDA Adverse Event
    Malfunction ·Product code FPA·February 22, 2008

    IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FAD·August 28, 2023

    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

    VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT KIT

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FAD·July 6, 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

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024