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Sources: EU EUDAMED, US FDA
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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
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
Bronchial One Lumen Tube - Right
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015
Bronchial One Lumen Tube - Left
FDA Enforcement
Class II
·Terminated·Teleflex, Inc.·August 26, 2015
R¿SCH 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 Enforcement
Class II
·Terminated·Teleflex, Inc.·February 25, 2015
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 Enforcement
Class I
·Terminated·Teleflex, Inc.·February 18, 2015
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
FDA Enforcement
Class II
·Ongoing·TELEFLEX MEDICAL INC·June 1, 2022
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile.
FDA Enforcement
Class II
·Ongoing·TELEFLEX MEDICAL INC·June 1, 2022
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
FDA Enforcement
Class II
·Terminated·TELEFLEX MEDICAL INC·February 26, 2020
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-56K p) 6.0 mm, REF MDP-60K
FDA Enforcement
Class II
·Terminated·TELEFLEX MEDICAL INC·February 26, 2020
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
FDA Enforcement
Class II
·Terminated·TELEFLEX MEDICAL INC·February 19, 2020
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
FDA Enforcement
Class II
·Terminated·TELEFLEX MEDICAL INC·February 19, 2020