BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    D·Kutting™ PTA Scoring Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UTF STEM-REDUCED, ADDITIONAL SIZES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COBRA COOLED SURGICAL PROBE, MODEL M004159670

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3.5MM TI CORTEX SCREW 30MM

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·November 6, 2017

    TRUETRACK

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·April 19, 2019

    ACRYSERT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code KYB·November 14, 2008

    FLEXIBLE ALLIGATOR GRASPER

    FDA Adverse Event
    Malfunction ·STORZ·Product code HIH·August 26, 2011

    MECHANICAL WALKER

    FDA Adverse Event
    Malfunction ·FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.·Product code ITJ·October 4, 2012

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025

    Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014