BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    RIWOtrack Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101179·GILL CORNEAL KNIFE STRAIGHT

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522307000·

    TALOS®-C

    FDA UDI
    SpineArt SA·07640375236708·STERILE TALOS®-C (HA) PEEK CONVEX IBFD

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702999631·ELVAREX 4/THIGH HIGH/CLOSED TOE/DOTTED 2,5 CM ...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16721312307000·

    CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2024

    MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    BARD SILICONE CHANNEL DRAING

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code GBX·August 17, 2011

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Injury ·INVACARE SUZHOU·Product code FSA·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

    FDA Enforcement
    Class II ·Terminated·Epocal·August 21, 2013

    GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    SIGNA Architect, Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 4, 2024

    GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026