BEUDAMED
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    FRESENIUS DRY ACID DISSOLUTION UNITS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799007193·

    Kendall

    FDA UDI
    Cardinal Health, Inc.·10884527014484·Scalpel #11

    Kendall

    FDA UDI
    Cardinal Health 200, LLC·10192253051834·Scalpel

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694033800·Low Profile 24 Hole Straight Plate

    RELAY POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    P4-FITNESS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523156481·Tesera-k ALIF, 31W X 26D, 11mm, 12° Trial

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151561·Tesera-k SA, 31mm X 26mm X 11mm, 12° Lordosis, T3

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523157235·Tesera-k ALIF, 31W X 26D, 11mm, 12° Broach

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·September 14, 2018

    CADENCE PHYSIO QC ADULT RTS

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MLN·May 17, 2013

    ENTRUST AT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011

    LUSTER HIP SZ 2 HIGH OFFSET

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·October 1, 2014

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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