6 results
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42ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
FDA Recall
Terminated
·Instratek, Incorporated·Product code NBH·September 18, 2012
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
FDA Enforcement
Class II
·Terminated·Instratek, Incorporated·March 20, 2013
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
FDA Enforcement
Class II
·Terminated·Instratek, Incorporated·October 1, 2014
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
FDA Enforcement
Class II
·Terminated·Instratek, Incorporated·December 30, 2015
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
FDA Recall
Terminated
·Instratek, Incorporated
15200 Middlebrook Dr
Ste G
Houston TX 77058-1216·Product code HWC·April 25, 2013
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
FDA Recall
Terminated
·Instratek, Incorporated
15200 Middlebrook Dr Ste G
Houston TX 77058-1217·Product code HRX·November 24, 2015