BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    HRSpheres Narrow-Size Embolic Microspheres

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154629374·3-D PLATE, CURVED, PROFILE HEIGHT 1.5MM

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180109377·5MM DIA., 45 CM INSULATED L-HOOK ELECTRODE, SID...

    ALPHA DX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TELAMON PEEK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TELAMON FUSION DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016

    TELAMON® FUSION DEVICE

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012

    TELAMON® FUSION DEVICE

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 25, 2014

    ACRYSOF TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·August 10, 2011

    UNIFY CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·September 17, 2021

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·June 20, 2024

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021