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

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    STACHROM PROTEIN C TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710391·GC Initial™ LF Opaqus Dentin ODB4, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705763·GC Initial™ LF Opaqus Dentin ODB4, 20g

    Assut Filbloc Permanent Sutures

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

    MISSION OLYMPUS AU ISE CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT PING ENHANCED 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

    FEMORAL TRIAL SLAPHAMMER

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code NPJ·June 26, 2015

    Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

    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