BEUDAMED
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    VITREA IMAGE DENOISING SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017743·K-Wire, Double Ended, Trocar Point, Diameter Si...

    HARMONY VLED SURGICAL LIGHTNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

    SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·February 8, 2021

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 3, 2014

    ALTRX +4 10D 36IDX54OD

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 31, 2013

    3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE

    FDA Adverse Event
    Injury ·3M HEALTH CARE·Product code KKX·June 16, 2011

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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