BEUDAMED
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    Left Atrial Catheter Set

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Laser Meter, Model No. LTM80, K-TEK, Prairieville, LA 70769

    FDA Recall
    Terminated ·K Tek·Product code K--DD·November 3, 2006

    Laser Distance and Level Transmitters, Model No. LT4C, ASI, 8570 Katy Freeway, Suite 117, Houston, TX 77024

    FDA Recall
    Terminated ·K Tek·Product code K--DD·November 3, 2006

    LaserTrak, Model No. LT80, ASI, Houston, TX 77024

    FDA Recall
    Terminated ·K Tek·Product code K--DD·November 3, 2006

    Laser Distance and Level Transmitters, Model No. LM02, K-Teck, 18321 Swamp road, Prairieville, LA 70769

    FDA Recall
    Terminated ·K Tek·Product code K--DD·November 3, 2006

    Laser Distance and Level Transmitters, Model No. LM200, K-Tek, Prairieville, LA 70769

    FDA Recall
    Terminated ·K Tek·Product code K--DD·November 3, 2006

    Laser Level Transmitters, Model No. LM4C, K-TEK, 18321 Swamp Road, Prairieville, LA 70769

    FDA Recall
    Terminated ·K Tek·Product code K--DD·November 3, 2006

    Laser Distance and Level Transmitters, Model No. LT200, ASI, Housotn, TX 77024

    FDA Recall
    Terminated ·K Tek·Product code K--DD·November 3, 2006

    Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDF·April 6, 2016

    Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FAM·April 6, 2016

    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code ODG·April 6, 2016

    Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDF·April 6, 2016

    Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code GCJ·April 6, 2016

    Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDT·April 6, 2016

    Ultrasound probe cover, sterile. Catalog No. 910811.

    FDA Recall
    Terminated ·North Coast Medi-Tek Inc·Product code KKX·June 7, 2005

    Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies

    FDA Recall
    Terminated ·North Coast Medi-Tek Inc·Product code LOR·May 13, 2011

    E-Z-EM brand, Basic biopsy tray, catalog no. 4125.

    FDA Recall
    Terminated ·North Coast Medi-Tek Inc·Product code LRO·June 23, 2004

    SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.

    FDA Recall
    Terminated ·North Coast Medi-Tek Inc·Product code LRO·January 18, 2005

    Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd., Cork, Ireland. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Titanium Greeenfield Vena Cava Filter comes preloaded in a jugular or a femoral introducer catheter.

    FDA Recall
    Terminated ·Boston Scientific Scimed·Product code DTK·August 5, 2005

    Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DTK·March 29, 2013