BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Humelock Reversed Shoulder

    FDA UDI
    FX SOLUTIONS·03701037303863·HUMELOCK REVERSED STEM TA6V CEMENTED Ø40/14

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00844856067431·4.0mm Variable Angle, Self-Tapping Hexalobe Scr...

    NTI

    FDA UDI
    NTI - Kahla GmbH Rotary Dental Instruments·E310134014FFG1·NTI Diamond TDF6 Fine FG

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312TC1343140141·TC Finishing instruments FG

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376695068·PROXIMITY FA SELF-TAP SCREW, 4.0 x 14mm

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376329604·4.0mm Fixed Angle, Self-Tapping Screw, Single L...

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376545912·SPS FA Self-Tap Screw, 4.0 x 14 mm

    SUREFIX INTERSPINOUS FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPI CONTACT DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    NOVOLOG FLEXPEN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON PEN LIMITED·Product code FMI·January 6, 2022

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 31, 2024

    TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWQ·December 3, 2019

    4.0MM SELF-TAPPING, HEXALOBE SCREW, 14MM (TI-6AI-4V ELI)

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code KWQ·June 2, 2017

    SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWQ·February 2, 2018

    OT VERIO IQ METER

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

    UNKNOWN DEPUY POLY LINER

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

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code OJX·June 20, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

    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