8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
FDA 510(k)
FDA Class 2
·Cardiovascular
Eclipse System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 31, 2012
SMALL BATTERY DRIVE 14.4V BATTERY
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code MOQ·November 14, 2014
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·September 16, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 26, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021