18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776371425·Oral Surgery Exodontia Cryer
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028398·
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
FDA 510(k)
FDA Class 2
·Immunology
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 6, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 12, 2018
TRIAGE CARDIAC HS PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 22, 2019
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code MMI·May 18, 2018
TRIAGE CARDIAC PANEL KIT
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code JHX·April 18, 2018
TRIAGE CARDIAC HS PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 21, 2019
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code MMI·October 5, 2017
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013
XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 16, 2011
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·November 1, 2018
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code MMI·May 17, 2017