114 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·October 8, 2014
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 28, 2016
Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014
RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTR·December 12, 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
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
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
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
FDA Recall
Terminated
·Teleflex, Inc.·Product code BYD·December 4, 2014
White Bronchial Double Lumen Tube Set (Right) Sterile
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015
Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015
Bronchial Double Lumen Tube Set (Left), Sterile
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015
Bronchial Double Lumen Tube Set (Right), Sterile
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015
Tracheopart Set (Left), Sterile
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015
Tracheopart Set (Right), Sterile
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015