BEUDAMED
    19 results · 22ms · 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 ×

    SOMNOscreen plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772344123·PROTECT.PRO ACTION BACK SUPPORT BLACK L

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694019408·HPS 2.4mm Screw & Plate Module

    24M - Southwest Gas Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588010441·24M - Southwest Gas Corp

    ROMIAPEX MODEL A-15

    FDA 510(k)
    FDA Unclassified ·Unknown

    CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Trilogy® Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024118515·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2011

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·October 27, 2014

    7.0MM TI SIDE-OPENING SCREW 45MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWQ·July 2, 2013

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON LABORATORIES, INC./HUNTINGTON·Product code HQL·August 17, 2007

    VISCOAT

    FDA Adverse Event
    Injury ·ALCON-BELGIUM, S.A. ALCON-COUVREUR N.V.·Product code LZP·August 17, 2007

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·December 21, 2010

    MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code MSS·November 30, 2022

    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    FDA Adverse Event
    Injury ·ALCON - COUVREUR N.V./ALCON - BELGIUM·Product code LZP·November 30, 2022

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    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