BEUDAMED
    33 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    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

    (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

    Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020

    Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

    FDA Enforcement
    Class II ·Ongoing·TELEFLEX MEDICAL INC·June 3, 2020