BEUDAMED
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    STIM PROBE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517565426·CoRoent Ant TLIF PEEK, 13x13x34mm 8°

    AGXO

    FDA UDI
    Oticon A/S·05707131260055·H110, MINIBTE 312 WL 85 SGR AGXO

    DIGIVIEW 250

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZILVER 518 BILIARY STENT

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 23, 2023

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QKP·February 11, 2021

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·June 15, 2011

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 22, 2008

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QKP·February 11, 2021

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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