BEUDAMED
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    ULTHERA SYSTEM

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

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583024394·CH60 MN, PS TT BE CHARM 60

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052829·4.0mm x 32mm Smooth Shaft Poly Screw Assm. The ...

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210167084·Smooth Shaft Polyaxial Screw, 4.0mm x 32mm

    METANEB

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PLV CONTINUUM VENTILATOR, MODEL P2000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT PING METER

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

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 23, 2013

    LCS COM RPSFLEX FEM CEM R STD+

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

    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

    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