13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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4D LV-ANALYSIS 3.0
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVIA Centaur® FER
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414177151·Ferritin - CENTAUR - RGT - 250 tests
DONJOY
FDA UDI
DJO, LLC·00888912205160·DONJOY ROM KNEE W/UNIT
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818271·Gelpi Retractor
FIBER ONE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
PROMUS ELEMENT? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 23, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011
NEOFLON PRO 26GA 0.6MM OD 19MM L INDIA
FDA Adverse Event
Malfunction
·Product code FOZ·September 22, 2021
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025