BEUDAMED
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    BASE IT

    FDA 510(k)
    FDA Class 2 ·Dental

    ELMED

    FDA UDI
    ELMED INCORPORATED·00198506059315·3 Fr. (1.0 mm), 40cm, Biopsy Cup Forceps-Serrat...

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00844856067516·4.0mm Variable Angle, Self-Tapping Hexalobe Scr...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K1430220·Rod Cutter, Table Top

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052775·4.0mm x 22mm Smooth Shaft Poly Screw Assm. The ...

    UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Dental

    SPEED SHIFT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

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

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 29, 2013

    LCS COMP RPSFLEX FEM CEM L LG

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code NJL·June 15, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    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