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

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    PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Leksell Vantage Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048304801·ARC SLIDE RIGHT

    OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·April 10, 2013

    BIOMET HIP FRACTURE FMRL

    FDA Adverse Event
    Injury ·BIOMET, INC.·Product code LZO·May 22, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 12, 2024

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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