3 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576
FDA Recall
Terminated
·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014