BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Materialise TKA Guide System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UROPLASTY RIGID ENDOSCPIC NEEDLES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AART PECTORALIS IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ALARIS SMARTSITE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·August 12, 2025

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 3, 2014

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON INC·Product code HET·August 24, 2011

    CURLIN INFUSION IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·July 1, 2013

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 29, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 10, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 22, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·December 27, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·September 16, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024