BEUDAMED
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    VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL IW17.5A INTRA OPERATIVE TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFIED VSM 2 VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EASYPUMPC-BLOC:RA,PCA&SAF 2-14:400ML, 2-14ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW, LLC·Product code MEB·May 30, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

    FDA Recall
    Terminated ·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009

    Set-Up Pack, part number PSS1305(C

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817906020151 T50 SN110 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

    FDA Enforcement
    Class II ·Ongoing·In2bones USA, LLC·June 17, 2026