BEUDAMED
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    CODMAN BACTISEAL CATHETERS

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00533221·

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134

    QUASAR

    FDA UDI
    Modus Medical Devices Inc·G34350033220·RESP-MP Insert Adapter

    Lumenis Pulse 30H

    FDA UDI
    LUMENIS LTD.·07290109145983·

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 10, 2021

    PERFORMER 30 HPS

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

    MODIFICATION TO PANAVIA F

    FDA 510(k)
    FDA Class 2 ·Dental

    ALLOCLASSIC, SL STEM, UNCEMENTED, 4, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·September 20, 2021

    SALIVARY STONE EXTRACTOR BASKET SSEB

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GCJ·August 3, 2017

    2520274-2013-10936

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

    CARDIAC READER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·March 1, 2011

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·February 27, 2008

    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 Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 18, 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 Recall
    Terminated ·Beckman Coulter Inc.·Product code KQO·March 2, 2018

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

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

    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 Recall
    Terminated ·Beckman Coulter Inc.·Product code LKM·October 28, 2019

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025