7 results
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7ms
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Sources: EU EUDAMED, US FDA
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
FDA Enforcement
Class II
·Terminated·EEG Info·December 26, 2012
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
FDA Enforcement
Class II
·Terminated·COVIDIEN LLC·October 10, 2018
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.
FDA Enforcement
Class II
·Terminated·Covidien LLC·May 2, 2018
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.
FDA Enforcement
Class II
·Terminated·Covidien LLC·May 2, 2018
Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·March 30, 2016
Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.
FDA Enforcement
Class II
·Terminated·Bradshaw Medical Inc.·May 18, 2016
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·October 2, 2013