BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044735·Forcep Extracting

    TruForm

    FDA UDI
    Rmo, Inc.·00885797100009·MN 1MOL BD KT STD N/L UNIV 176

    SURE-T PARADIGM/MINIMED SURE-T

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

    MINIMED SURE-T

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 17, 2024

    HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PORTEX GENERAL ANESTHESIA CIRCUITS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 16, 2011

    SEQUOIA

    FDA Adverse Event
    Injury ·ABBOTT SPINE·Product code KWP·February 26, 2008

    PRESIDIO 10 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024