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

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    LUTEMOLL (BIOPLAST)

    FDA 510(k)
    FDA Class 2 ·Dental

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710381·GC Initial™ LF Opaqus Dentin ODB3, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705756·GC Initial™ LF Opaqus Dentin ODB3, 20g

    THERMOMETER, SINGLE USE, STRIP, TEMPADOT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Hearing Healthcare Pro

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    1-DAY ACUVUE TRUEYE NARAFILCON A

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·October 8, 2010

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·December 12, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40

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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015