BEUDAMED
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    Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·September 19, 2018

    N Latex CDT Kit

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·September 5, 2018

    Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·October 9, 2019

    Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·December 12, 2018

    Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC culture identification kits.

    FDA Enforcement
    Class II ·Terminated·Opgen Inc·July 25, 2018

    MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 8, 2018

    Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·July 25, 2018