BEUDAMED
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    Bilicocoon™ Phototherapy System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111284663·TC METZ SCISS CVD DEL B/B 5.75

    Custom 6x95mm P-rom Stem Reamer

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215139384·

    CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 10, 2014

    INTRALASE FS1 LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code HNO·November 10, 2010

    SYNERGY

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·June 11, 2013

    ROOT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·September 20, 2018

    Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; 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

    Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

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

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016