BEUDAMED
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    OBC-149 BREAST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964023000·The ENDO CARRY-ON Procedure Kit contains all of...

    FORESTAFLEX®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20033401·Six-twist-wires pref. .016"

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450467367·

    FacetFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361020103·Facet Screw Assy, SOTW, 6.0 x 40mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130542·3.0mm, 3.5mm 4.0mm Caddy for use with Large Tray

    HYSTALOG HSG CATHETER

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

    STACKABLE CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINOX SMART SD 65/18

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

    PRECISION XTRA

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

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP·Product code NBW·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

    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

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024