11 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·June 20, 2014
PALOMAR DERMALUX PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code BSP·November 21, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
TEMPERATURE/FLOW PROBE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 30, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·May 2, 2013
IMRI SHORT HD ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBB·September 15, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 5, 2023