BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

    FDA Enforcement
    Class II ·Terminated·Accumetrics Inc·March 19, 2014

    BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·February 4, 2026

    ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 15, 2012

    Genesis Push-In Suture Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Fixone Biocomposite Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Genesis Knotless Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Genesis Dual Thread Screw-In Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Genesis Screw-In Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    AlternatiV+ Max Knotless Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    AlternatiV+ Screw-In Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Fixone Hybrid Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026