BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    SILBRONCHO (LEFT LUNG)

    FDA UDI
    FUJI SYSTEMS CORPORATION·04544050061193·SILBRONCHO Tube is intended for use in airway m...

    SILBRONCHO (LEFT LUNG)

    FDA UDI
    FUJI SYSTEMS CORPORATION·04544050123952·SILBRONCHO Tube is intended for use in airway m...

    SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 17, 2021

    SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 16, 2021

    NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HARDYDISK RIFAMPIN, 5MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 12, 2021

    ARIS

    FDA Adverse Event
    Malfunction ·COLOPLAST MANUFACTURING US, LLC·Product code FTL·October 17, 2008

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2013

    VASSALLO GT

    FDA Adverse Event
    Injury ·FILMECC CO., LTD.·Product code DQX·October 3, 2024

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025