BEUDAMED
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    VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·May 6, 2011

    Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·May 6, 2011

    INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code OWB·December 29, 2017

    "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012

    "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012

    "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012

    "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012

    "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012

    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·July 10, 2013

    INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·March 14, 2018

    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IXR·October 21, 2004

    NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012

    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 15, 2015

    Sterile, Drape, Headset, Lower, Part Number 888944-01.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    Sterile, Drape, Headset, Upper, Part Number 888945-01.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code OWB·March 11, 2015

    Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·December 31, 2014

    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·May 22, 2013