9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 20, 2017
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
FDA 510(k)
FDA Class 2
·Radiology
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
FDA 510(k)
FDA Class 2
·General Hospital
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN.
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 11, 2017
ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKZ·September 16, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
YC-1800
FDA Adverse Event
Malfunction
·NIDEK CO., LTD·Product code LZS·August 22, 2014
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