12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SILDENT
FDA 510(k)
FDA Class 2
·Dental
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
FDA 510(k)
FDA Class 1
·Dental
COOK CODA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 29, 2023
THE EMAX 2 PLUS SYSTEM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2014
ACIS IMPLANT INSERTER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·May 29, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·June 17, 2011
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 18, 2015
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PKL·July 19, 2021
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2022
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 3, 2016
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 2, 2016