BEUDAMED
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    BINOCULAR OPERATING MICROSCOPES &

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788220090·10mm Left Handed Nerve Root Retractor

    18M - Class A 21 White Cap - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620091·18M - Class A 21 White Cap - Metal

    Partial Pelvis Replacement

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575048649·Hook for obturator foramen

    AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    KARL STORZ

    FDA Adverse Event
    Injury ·KARL STORZ ENDOSCOPY·Product code KQT·January 21, 2004

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·May 20, 2014

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code KOG·April 6, 2010

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 1, 2012

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018