BEUDAMED
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    GYRUS PLASMA SKIN RESURFACING SYSTEM

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

    MetaSystems Probes

    FDA UDI
    MetaSystems Probes GmbH·04251315807099·XL FGFR1, 10x 100µl, Break Apart

    MetaSystems Probes

    FDA UDI
    MetaSystems Probes GmbH·04251315818057·CL CDKN2A/NF1, 10x 100µl

    CARTO XP SYSTEM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, LTD·Product code DQK·November 30, 2007

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 14, 2008

    MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRIPPER PLUS NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)·Product code DQK·April 17, 2008

    PELVICOL 2CM X 7CM 1.0MM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·April 3, 2013

    V.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KCI USA, INC.·Product code OMP·March 31, 2011

    ENDOTAK ENDURANCE EZ

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    ADVIA CENTAUR XPT

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 19, 2016

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·August 3, 2022

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·February 16, 2023

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 25, 2023

    BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·October 17, 2022

    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025