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

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    MODIFICATION TO GEO STRUCTURE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450149027·

    NAMILON POWDER

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI200401680·NAMILON POWDER 1 OZ SHADE 68

    PYROPLAST POWDER

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI100401680·PYROPLAST POWDER 1 OZ SHADE 68

    MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007

    UNKNOWN DEPUY DEVICE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWY·April 8, 2013

    TEGO CONNECTOR

    FDA Adverse Event
    Other ·ICU MEDICAL, INC.·Product code FPA·March 21, 2011

    SERVO-I

    FDA Adverse Event
    Death ·MAQUET CRITICAL CARE AB·Product code CBK·May 2, 2008

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013