BEUDAMED
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    ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885556600047·O*MTO SCR ENDO-FIX TAP 7MM DIA - SOD

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00844856067455·4.0mm Variable Angle, Self-Tapping Hexalobe Scr...

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376329628·4.0mm Fixed Angle, Self-Tapping Screw, Single L...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197471404·Verhoeven-Rosen Suction Tube Ø1,6mm...

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376545936·SPS FA Self-Tap Screw, 4.0 x 16 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376695082·PROXIMITY FA SELF-TAP SCREW, 4.0 x 16mm

    LIFESPAN EPTFE VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMPI PHOENIX

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWQ·December 15, 2015

    OT PING ENHANCED METER

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

    EON MINI

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

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 20, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035; 4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040; 2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025; 3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030; 3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035; 4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040; 4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045; 5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050; 5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055

    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