BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108698480·Straight Paltop Equator Abutment Conical H4mm

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00190376077611·Polyaxial Reduction Screw, 7.2 mm x 70 mm

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00844856086791·POLYAXIAL REDUCTION SCREW, 7.2mm X 70mm

    Optimus Drill Q – 4.5mm 40mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215061784·

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00190376074153·Polyaxial Screw, 7.2 mm x 70 mm

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215023324·

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00844856085619·SACRAL POLYAXIAL SCREW, 7.2mm X 70mm

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00844856084469·POLYAXIAL SCREW, 7.2mm X 70mm

    BIOLOK SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORALLITE COMPREHENSIVE EXAM TRAY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Crescendo Meniscal Insert PS 15mm Size 0

    FDA UDI
    AMPLITUDE SAS·03701089525282·

    ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 22, 2013

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·April 21, 2011

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024