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

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    ACCUSONIC ADVANTAGE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ARGEDENT 3 (5 dwt)

    FDA UDI
    ARGEN CORPORATION, THE·D818120171·Gold based noble metal

    Diversatek Healthcare

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·M7831201710·Endoscopy Basic Procedure Kit w/o Suction Tubing

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COOLBLU2 DENTAL RESIN CURING DEVICE

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 1, 2022

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 25, 2020

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 25, 2022

    DL MOTOR PREASSMBL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·May 20, 2013

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·September 25, 2014

    CENTURY BED

    FDA Adverse Event
    Death ·HILL-ROM, INC.·Product code FNL·June 2, 2011

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FRN·April 22, 2024

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FRN·January 11, 2024

    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·February 25, 2026

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020