108 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
FDA Recall
Terminated
·Parks Medical Electronics Inc·Product code DPW·November 8, 2007
Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Bronchial Double Lumen Tube Set (Right), Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Tracheopart Set (Right), Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bronchial intubation; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16037
FDA Recall
Terminated
·Teleflex Medical·Product code BTS·September 27, 2006
Bronchial One Lumen Tube - Left
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Bronchial One Lumen Tube - Right
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Bronchial Double Lumen Tube Set (Left), Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.
FDA Recall
Terminated
·Teleflex Medical·Product code BTS·February 28, 2014
White Bronchial Double Lumen Tube Set (Right) Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Tracheopart Set (Left), Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
FDA Recall
Terminated
·Arrow International Inc·Product code LJS·April 11, 2018
Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 6, 2018
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
FDA Recall
Terminated
·Arrow International Inc·Product code PND·April 23, 2019
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 26, 2019
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
FDA Recall
Terminated
·Deerfield Imaging·Product code LNH·February 10, 2016
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
FDA Enforcement
Class II
·Terminated·Deerfield Imaging·March 23, 2016
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
FDA Enforcement
Class II
·Terminated·Deerfield Imaging, Inc.·May 16, 2018
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.
FDA Recall
Terminated
·BTE Technologies, Inc.·Product code ISD·April 9, 2015