BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·November 17, 2009

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609690·MAQUET 3" DELUXE

    RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS

    FDA 510(k)
    FDA Unclassified ·Unknown

    OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    ILS 29MM, CURVED

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 26, 2013

    CRYSTALENS ACCOMMADTING IOL

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·August 29, 2014

    GREENLIGHT HPS LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 14, 2011

    PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025

    PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026

    LGN PRSFT STEM 10MMX220MM STRT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017

    LEGION HK HINGE KNEE SYSTEM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025

    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

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020