3,875 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
FDA Recall
Terminated
·International Biophysics Corp.·Product code DTS·August 7, 2015
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
Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10053, d) DLP Suction Tube 10 Fr. Shaft with 20 Fr. Pool Tip, Model Number: 10060, e) DLP Suction Tube 16 Fr. Shaft with 20 Fr. Fluted Tip, Model Number: 10061
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DTS·March 19, 2024
SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTS·September 13, 2011
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
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTS·February 5, 2008
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
FDA classification
FDA Class 2
·Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Tube, Bronchial (W/Wo Connector)
FDA classification
FDA Class 2
·Tube, Bronchial (W/Wo Connector)
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
FDA Enforcement
Class II
·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·October 30, 2024
PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Enforcement
Class III
·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
FDA classification
FDA Class 1
·Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control