13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMAGENMD WITH IMAGENQ
FDA 510(k)
FDA Class 2
·Radiology
3D
FDA UDI
Rmo, Inc.·00885797100160·3D QUAD HELIX WILSON ASST OF 6
multiSTATION™
FDA UDI
LSI Solutions, Inc.·00850012846352·DOC-X 25™ EXTENDER
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607399·SKYTRON 3600 2" SOFTCARE
PROVIEW MEDICAL IMAGE DISPLAY MODULE
FDA 510(k)
FDA Class 2
·Radiology
BCI ADVISOR VITAL SIGNS MONITOR (9200)
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
SERIES A PAT W/WR THN 28 1 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 12, 2022
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 26, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 6, 2011
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·July 23, 2008
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017