BEUDAMED
    31 results · 19ms · Sources: EU EUDAMED, US FDA

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    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    FDA Enforcement
    Class II ·Terminated·Lumenis Ltd·May 25, 2016

    REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·March 6, 2013

    Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.

    FDA Enforcement
    Class II ·Terminated·Vygon Corporation·March 20, 2013

    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.

    FDA Recall
    Terminated ·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code CDP·May 6, 2015

    enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). COMMON NAME: enGen Track System. The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 6, 2015

    Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·September 2, 2015

    CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015