BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT

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

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X400MM X 1

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 13, 2012

    PAIN CARE 3200

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012

    LC4200 PCA AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·October 20, 2010

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·June 2, 2010

    IMPLANT HOLDER

    FDA Adverse Event
    Malfunction ·SYNTHES·Product code FZX·January 14, 2013

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·November 30, 2010

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 3, 2014

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; 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 FD20/20 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

    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