11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ortho System
FDA 510(k)
FDA Class 2
·Dental
BR Surgical, LLC
FDA UDI
BR Surgical, LLC·00840183504861·ADSON TUBIANA Tissue & Suture Forceps, with tyi...
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINITY MCABLE - MAINSTREAM CO2
FDA 510(k)
FDA Class 2
·Anesthesiology
VENTILATOR, CONTINUOUS, FACILITY USE
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·July 7, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 20, 2013
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MAF·September 29, 2008
TASUKI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 6, 2019
BD LARGE SHARPS CONTAINERS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·May 9, 2023
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018