BEUDAMED
    19 results · 19ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001203·artVeneer life upper anteriors, BM, B2

    Scanlan® TIP-GUARD™ instrument protectors - Clear

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159001884·Scanlan® TIP-GUARD™ instrument protectors - Cle...

    TruFlex™

    FDA UDI
    Ortho Organizers, Inc.·00190707126612·TRUFLEX NiTi Thermal Euro Lower 016 (10pk)

    TruFlex

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730013927·NiTi Thermal Euro Lower 016 10 archwires per pack

    Plasma IQ Electrode Curved (1 piece)

    FDA UDI
    NEAUVIA NORTH AMERICA, INC.·00850017374102·1 curved electrode for used with Plasma IQ

    4.0 X 12mm CANN SCREW FASTENER Ti FL THD

    FDA UDI
    Osteocentric Technologies, Inc.·00810074304610·4.0 X 12mm CANN SCREW FASTENER Ti FL THD

    HARDYDISK, KANAMYCIN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Z-NET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 24, 2011

    ASCENSIA CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 14, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012

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

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