BEUDAMED
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    FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, SCS·July 18, 2018

    Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, SCS·July 18, 2018

    Discovery IGS 740 Interventional Fluoroscopic X-ray Systems

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, SCS·July 18, 2018

    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·July 4, 2018

    CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.

    FDA Enforcement
    Class II ·Terminated·Trophy Sas·May 8, 2013

    CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.

    FDA Enforcement
    Class II ·Terminated·Trophy Sas·May 8, 2013

    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 1, 2014

    TD-Synergy. Laboratory Information System.

    FDA Enforcement
    Class II ·Terminated·Technidata S.A.·May 29, 2013

    ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Enforcement
    Class II ·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014

    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

    FDA Enforcement
    Class II ·Terminated·PEROUSE MEDICAL·January 7, 2015

    API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.

    FDA Enforcement
    Class II ·Terminated·Biomerieux France Chemin De L'Or·February 5, 2014

    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.

    FDA Enforcement
    Class II ·Terminated·Perouse Medical·July 30, 2014

    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014

    Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures

    FDA Enforcement
    Class II ·Terminated·PEROUSE MEDICAL·January 7, 2015

    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.

    FDA Enforcement
    Class II ·Terminated·BIOMET FRANCE S.A.R.L.·June 17, 2015

    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·July 8, 2015