47 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tempus Pro Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776319557·Middle Ear Mirror, Angled
Bausch + Lomb
FDA UDI
Bausch & Lomb Incorporated·00757770423743·MIRROR MIDDLE EAR HOUSE 2MM
JEDMED
FDA UDI
JEDMED INSTRUMENT COMPANY·M633301705670·MIRROR MIDDLE EAR HOUSE 45-DEG ANG
PEARL DIABETES MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
C.T.M. MOBILITY SCOOTER HS515(3W)
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 30, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·April 3, 2020
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code NVY·October 9, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 21, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 23, 2015
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 26, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·September 26, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·February 4, 2020
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·July 9, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·July 3, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·October 12, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 7, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·February 11, 2020