BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Sharps container

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FAC-4 - Duke Power Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet

    FAA Airline - 24 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013237·FAA Airline - 24 Metal

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450239568·

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025

    ULTIMA METAL-ON-METAL ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAQUET SAS

    FDA Adverse Event
    Malfunction ·MAQUET S.A.S·Product code FSY·June 26, 2013

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERAITONS CO.·Product code LGW·October 17, 2008

    EON MINI 16 - CHANNEL RECHARGEABLE IPG

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011

    OPTIFLOW FILTERED NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 16, 2023

    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

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 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