BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    REMCORE REMOTE CONTROLLED OXYGEN REGULATOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490882750·INSTRUMENT 9060265 CURVED ANT SPREADER

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"

    BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265

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

    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROGRASP (TM) FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 12, 2012

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 16, 2013

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·June 11, 2008

    ANCHORLOK(R) SOFT TISSUE ANCHOR

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code MBI·April 15, 2011

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022