BEUDAMED
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    Infrared Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012818·K-Wires, Double diamond, .054-inch (1.4mm) diam...

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049439·K-Wires, Double diamond, .054-inch (1.4mm) diam...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293067·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111388705·MICRO MOSQ FCP STR 1X2 4"

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383552653·Gutta Percha Points is used to root canal filin...

    GUARDIAN CONNECTION

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

    ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOLDTRACE FETAL SCALP ELECTRODE

    FDA Adverse Event
    Malfunction ·CLINICAL INNOVATIONS, LLC·Product code HGP·February 21, 2018

    COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020

    STERRAD 100S STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 14, 2013

    4C -ES CELL CONTROL

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JPK·July 1, 2011

    ISOMED NON-PROGRAMMABLE PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 22, 2008

    ACCESS ACCUTNI REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025