BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard MC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard MC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset MC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset MC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard MC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset MC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard MC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset

    FDA Enforcement
    Class II ·Ongoing·NuVasive Specialized Orthopedics, Inc.·December 21, 2022

    NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be sterilized by the end user).

    FDA Enforcement
    Class II ·Terminated·NuVasive Inc·May 13, 2020

    MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

    FDA Enforcement
    Class II ·Ongoing·Globus Medical, Inc.·April 30, 2025

    Description/REF: ACCESS TRAY/ASK-04001-MC3

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP¿ 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP¿ 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP¿ 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP¿ 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP¿ 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP¿ 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP¿ 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP¿ 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP¿ 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP¿ 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP¿ 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP¿ 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP¿ 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP¿ 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP¿ 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP¿ 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP¿ 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2¿ 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2¿ 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2¿ 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2¿ 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2¿ 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2¿ 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2¿ 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2¿ 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·May 22, 2024

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·November 26, 2025

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

    FDA Enforcement
    Class II ·Terminated·Myolyn Inc.·August 24, 2022

    NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E

    FDA Enforcement
    Class II ·Ongoing·Mc3 Inc·March 27, 2024

    NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E

    FDA Enforcement
    Class II ·Ongoing·Mc3 Inc·March 27, 2024

    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·October 3, 2012

    KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013

    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013

    KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013