BEUDAMED
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    Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests

    FDA Enforcement
    Class II ·Terminated·Exact Sciences Corporation·June 7, 2017

    PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.

    FDA Recall
    Terminated ·Merz North America, Inc.·Product code MIX·October 26, 2015

    DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.

    FDA Enforcement
    Class II ·Terminated·Musculoskeletal Transplant Foundation, Inc.·April 29, 2015

    DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.

    FDA Recall
    Terminated ·Musculoskeletal Transplant Foundation, Inc.·Product code MQV·December 4, 2014

    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·February 19, 2014

    Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·December 4, 2013

    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·December 19, 2018

    Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·May 8, 2009

    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

    FDA Enforcement
    Class II ·Terminated·Valeant Pharmacueticals International·May 25, 2016

    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·February 25, 2015

    GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05

    FDA Recall
    Terminated ·GE Medical Systems Information Technologies·Product code LLZ·July 18, 2005

    Exacta-Mix 2400 pharmacy compounding system.

    FDA Recall
    Terminated ·Baxa Corporation·Product code NEP·November 7, 2003

    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

    FDA Recall
    Terminated ·Valeant Pharmacueticals International·Product code N/A·January 29, 2016

    CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS

    FDA Enforcement
    Class II ·Terminated·BIOPSYBELL S.R.L.·May 26, 2021

    iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

    FDA Recall
    Terminated ·Conformis, Inc.·Product code LPH·August 22, 2019

    iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

    FDA Recall
    Terminated ·Conformis, Inc.·Product code LPH·August 22, 2019

    Exacta-Mix Valve Set, Primary Valve Assembly

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·April 30, 2004

    CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS

    FDA Recall
    Terminated ·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021

    Exacta-Mix Valve Set, Primary Valve Assembly

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·April 30, 2004

    Exacta-Mix Valve Set, Secondary Valve Assembly

    FDA Recall
    Terminated ·Baxa Corporation·Product code LHI·April 30, 2004