BEUDAMED
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    HAKIM PROGRAMMER AND TRANSMITTER

    FDA 510(k)
    FDA Class 2 ·Neurology

    Premier Explorers

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783006216·Explorer DE_PA-CF 2

    Eckert & Ziegler Isotope Products, Inc.

    FDA UDI
    Eckert & Ziegler Isotope Products, Inc.·00810117211288·Attenuation Correction Line Source

    TruForm

    FDA UDI
    Rmo, Inc.·00885797100030·MN 2MOL BD KT STD NO/L R&L 178

    SCAN LT40 (40 CHANNELS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY

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

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 11, 2013

    HG MULTILOCK FEMORAL HIP STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·February 22, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·February 25, 2008

    iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KQO·January 30, 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

    iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·March 8, 2017

    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

    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