BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    MIROCAM CAPSULE ENDOSCOPE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Bard® Polyurethane Ureteral Catheters, Open Tip

    FDA UDI
    C. R. Bard, Inc.·10801741126892·Bard® Polyurethane Ureteral Catheters, Open Tip

    EVONOS GMBH & Co. KG

    FDA UDI
    Gyrus ACMI, LLC·00821925015418·VOCOM PERICHONDRIUM ELEV

    N/A

    FDA UDI
    Ortho Development Corporation·00822409116706·Neck Trial, STD, Size 10-12

    INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FHW·October 24, 1996

    NA

    FDA UDI
    STRYKER CORPORATION·04546540729583·5.0mm Caspar Blade

    RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SDS-4I

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ulrich

    FDA UDI
    Avalign Technologies, Inc.·00190776397371·Cup Curette, #3 45° Down

    ROCCIA

    FDA UDI
    Silony Medical GmbH·04054896028064·ROCCIA MultiLIF Cage 13 x 40 mm, 5° Lor.

    BD AUTOSHIELD DUO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 14, 2022

    OT VERIO IQ METER

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

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·May 1, 2013

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 20, 2011

    Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4157.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005

    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