BEUDAMED
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    BIO-CONSOLE 560

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERCUTANEOUS INTRODUCER, MODEL 10383-XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    6.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·April 26, 2013

    DLP CARDIAC SUMP

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code DTS·September 4, 2014

    30327 12CC 100 UNIT HEP SYR {CAN} (5CC)

    FDA Adverse Event
    Malfunction ·TYCO HEALTHCARE/KENDALL·Product code NZW·July 23, 2008

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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