9 results
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17ms
·
Sources: EU EUDAMED, US FDA
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471149830·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.5mm DIA...
BOBBY Balloon Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
AMNIOSTAT-FLM-PG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·June 16, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·February 11, 2013
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·January 10, 2011
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025