BEUDAMED
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    Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)

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

    LACTOSORB® SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036123079·

    LACTOSORB® SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00888233012164·

    SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190

    FDA 510(k)
    FDA Class 2 ·Radiology

    2027971-2024-152095

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·December 4, 2024

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·July 7, 2022

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code LDF·October 8, 2014

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 16, 2013

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 7, 2011

    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

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

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