BEUDAMED
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    Vital Sync Informatics Manager & Virtual Patient Monitoring Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821607180·

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154020607·Cruciate Retaining Tibial Insert

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024619·B-P MODULAR EXTENSION W/ULTRACOAT - 18 MM X 175 MM

    AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CELL-CHEX WITH CPPD CRYSTALS

    FDA 510(k)
    FDA Class 2 ·Hematology

    PNEUPAC PARAPAC VENTILATOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTL·November 1, 2018

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 30, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2008

    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018