BEUDAMED
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    Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    FDA Recall
    Terminated ·NEO METRICS, INC.·Product code OCY·March 31, 2014

    Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Wire Guide, Guidewire, Global Product Number G14326

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI¿ Remote Alarm Cable is designed for use with the 9004 Capnocheck¿ Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck¿ Capnography system to a remote alarm system. The BCI¿ Remote Alarm Cable and the 9004 Capnocheck¿ Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·April 10, 2013

    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

    FDA Enforcement
    Class II ·Terminated·AcuFocus, Inc.·March 30, 2016

    MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·August 18, 2021

    Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 10, 2015

    Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI Remote Alarm Cable is designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck Capnography system to a remote alarm system. The BCI Remote Alarm Cable and the 9004 Capnocheck Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CCK·February 6, 2013

    BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code MWI·June 5, 2007

    BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DXN·April 2, 2008

    Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CCK·March 21, 2015

    ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·August 13, 2010

    ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·August 13, 2010

    ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·August 13, 2010