BEUDAMED
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    PARI-MASTER MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377070876·RELINE C Screw, 5.5x40mm MA Thoracic

    Valencia Pedicle Screw System

    FDA UDI
    Altus Spine, LLC·B41799355401·5.5mm x 40mm Triple Lead Closed Head Screw

    MODEL 3587A RESUME II LEAD

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESPIRONICS BIPAP REMOTE CONTROL UNIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code INK·December 4, 2010

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 30, 2013

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 15, 2014

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018