BEUDAMED
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    Entropy Module, E-ENTROPY-01

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Oticon A/S·05707131287915·RIA2 PRO TI, MINIRITE 312 WL TC

    OPIATE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IPACS PRISM-5.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:FLEX INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 22, 2019

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 9, 2023

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·January 8, 2021

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2013

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 7, 2011

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DQX·August 14, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Death ·COOK VANDERGRIFT INC·Product code DRB·August 23, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DQX·August 23, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·March 13, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DQX·November 8, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DQX·October 25, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRB·September 14, 2018

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012