BEUDAMED
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    Xenocor Xenoscope Laparoscopic System

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

    I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)

    FDA 510(k)
    FDA Class 2 ·Radiology

    G+ SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 14, 2013

    UNKNOWN MERIDIAN BEADED ST STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code LPH·July 18, 2011

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    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