BEUDAMED
    21 results · 28ms · Sources: EU EUDAMED, US FDA

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    Cetus system, Cetus probe

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 30, 2022

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·September 12, 2019

    SECURA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 14, 2013

    USA ELITE SYSTEM ROTATING CONTINUOUS

    FDA Adverse Event
    Other ·GYRUS ACMI, INC.·Product code FJL·June 30, 2011

    INJECTION GOLD PROBE BIPOLAR CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 11, 2008

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 2, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·February 12, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·March 8, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·February 18, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 3, 2020

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·January 2, 2020

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·July 26, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·November 20, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·November 8, 2019

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LIT·July 12, 2024

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·August 7, 2013