BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    Super Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023

    PPD BALLOON DILATATION CATHETER

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

    MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 10, 2020

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 12, 2017

    ESSURE

    FDA Adverse Event
    Other ·CONCEPTUS, INC.·Product code HHS·October 10, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 1, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2017

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code DTB·April 2, 2014

    ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    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