BEUDAMED
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    PREVANTICS DEVICE SWAB

    FDA 510(k)
    FDA Unclassified ·Unknown

    Oticon

    FDA UDI
    Oticon A/S·05707131258663·H15, RITE 312 WL SIL

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102749·BRIERLEY NUCLEUS SPLITTER

    NEIVERT NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896022218·NEIVERT NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED...

    EVOLUTION MP TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WAGNER CONE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·October 1, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·June 13, 2011

    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