BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    ELECSYS CA 15-3 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CompCore AF Tips

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783003772·Syringe Extra-fine intraoral tips

    Preat

    FDA UDI
    Preat Corporation·00842092169780·Straumann® BL RC-compatible ASC Engaging Ti Bas...

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964013544·The ENDO CARRY-ON Procedure Kit contains all of...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001468·artVeneer life upper anteriors, BS, D3

    NBS CONNECTING TUBE SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RANDOX COMPLEMENT C4

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 3, 2024

    DUAL EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

    CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·February 25, 2011

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    FDA Adverse Event
    Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·February 19, 2008

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

    FDA Enforcement
    Class II ·Terminated·Oxus America, Inc.·February 13, 2013

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    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