BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    VITROS Chemistry Products hsCRP Reagent

    FDA 510(k)
    FDA Class 2 ·Immunology

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024558·B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 175 MM

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154020584·Cruciate Retaining Tibial Insert

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·May 30, 2018

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 14, 2018

    RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VITELCARE C-TURTLE PATIENT MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHILIPS SONICARE

    FDA Adverse Event
    Injury ·PHILIPS ORAL HEALTHCARE·Product code JEQ·March 26, 2018

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 14, 2017

    PHILIPS SONICARE

    FDA Adverse Event
    Injury ·PHILIPS ORAL HEALTHCARE·Product code JEQ·April 16, 2018

    MELODY TRANSCATHER PULMONARY VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPV·June 14, 2017

    MELODY TRANSCATHER PULMONARY VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPV·June 14, 2017

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 30, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2008

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 3, 2019

    LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018