11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
Nexxis OR
FDA UDI
Barco NV·05415334036833·NEXXIS SYSTEM X620 CM V5
Arthrex®
FDA UDI
ARTHREX, INC.·00888867316768·LOW PROFILE CORTICAL SCW, TI, 5.0x32MM
NexGen® Complete Knee Solution
FDA UDI
Zimmer, Inc.·00889024202313·
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
FDA 510(k)
FDA Class 2
·Cardiovascular
PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
FDA 510(k)
FDA Class 2
·Cardiovascular
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 27, 2014
ACCENT DR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 9, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·November 22, 2010
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024