BEUDAMED
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    Nexgel Inc

    Manufacturer
    🇺🇸 United States

    NEXGEL, INC.

    FDA registration
    NEXGEL, INC.·2 products·🇺🇸 United States

    ProPharma Group The Netherlands BV

    Authorized representative
    🇳🇱 Netherlands·3 Manufacturers

    XCOIL Retractor

    FDA UDI
    Nexgen Medical Systems, Inc.·00855975007024·XCOIL Retractor - 12mm x 125cm (Short Eyelet)

    XCOIL Encapsulator

    FDA UDI
    Nexgen Medical Systems, Inc.·00855975007048·XCOIL Encapsulator - 11mm x 80cm

    XCOIL Retractor

    FDA UDI
    Nexgen Medical Systems, Inc.·00855975007062·Retractor 18mm x 125cm

    XCOIL Retractor

    FDA UDI
    Nexgen Medical Systems, Inc.·00855975007031·XCOIL Retractor - 12mm x 125cm (Long Eyelet)

    XCOIL Encapsulator

    FDA UDI
    Nexgen Medical Systems, Inc.·00855975007055·Encapsulator 16mm x 70cm

    ISOLEX 300I (PT ENROLLED ON STUDY W/IDE#BB-IDE 6474

    FDA Adverse Event
    Injury ·NEXELL THERAPEUTICS INC·Product code GKT·January 25, 2002

    NEXELL THERAPEUTICS TEDEX 300I

    FDA Adverse Event
    Death ·NEXELL THERAPEUTICS, INC.·Product code GKT·April 18, 2000

    CELL-PRO

    FDA Adverse Event
    Injury ·NEXELL THEAPEUTICS, INC.·Product code GKT·October 13, 1999

    ISOLEX STEM CELL REAGENT KIT

    FDA Adverse Event
    Malfunction ·NEXELL THERAPEUTICS INC.·Product code GKT·July 23, 1999

    ISOLEX 300I DISPOSABLE SET

    FDA Adverse Event
    Malfunction ·NEXELL THERAPEUTICS INC.·Product code GKT·August 13, 1999

    CELL-PRO

    FDA Adverse Event
    Death ·NEXELL THERAPEUTICS, INC.·Product code GKT·August 26, 1999

    CELL-PRO

    FDA Adverse Event
    Death ·NEXELL THERAPEUTICS, INC.·Product code GKT·August 30, 1999

    NEXELL

    FDA Adverse Event
    Malfunction ·NEXELL THERAPEUTICS INC·Product code KSE·August 14, 2001

    CRYOCYTE FREEZING CONTAINER WITH LABEL POCKET

    FDA Adverse Event
    Malfunction ·NEXELL THERAPEUTICS, INC.·Product code KSR·February 19, 1999

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011

    NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA

    FDA Enforcement
    Class II ·Terminated·Zimmer Trabecular Metal Technology, Inc.·December 31, 2014

    NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXH·April 16, 2010