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

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    GIGALASER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00844856067462·4.0mm Variable Angle, Self-Tapping Hexalobe Scr...

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981040963·Screw Self-Tapping - 4.0x17mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376695099·PROXIMITY FA SELF-TAP SCREW, 4.0 x 17mm

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376329635·4.0mm Fixed Angle, Self-Tapping Screw, Single L...

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376545943·SPS FA Self-Tap Screw, 4.0 x 17 mm

    VALENTINE STEEL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    JEJE TEETHER

    FDA 510(k)
    FDA Class 1 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code LPH·May 29, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 20, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015