BEUDAMED
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    ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.

    FDA Enforcement
    Class II ·Terminated·Data Innovations, LLC·September 24, 2014

    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref.: 74120160

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

    STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGP·March 13, 2007

    Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code MKT·June 13, 2007

    Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Ventilator System Servo-i V3.1 Maquet Critical Care PC1771

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

    Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code BRY·August 13, 2007

    Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·May 3, 2007

    Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile, Single Use Only, Order #: ft r 223, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051

    FDA Recall
    Terminated ·VISX INCORPORATED, A SUBSIDIARY OF AMO INC·Product code LZS·December 13, 2007

    BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LKJ·November 13, 2007

    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·December 16, 2013