35 results
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31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608815·MIDMARK 4" DELUXE
C. DIFF CHEK - 60
FDA 510(k)
FDA Class 1
·Microbiology
MACROPOREDX DISTRACTOR SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017
OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017
CARDIAC SURGERY PACK BO-TOP 36500
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 28, 2017
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
CUSTOM TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
CUSTOM TUBING PACKS
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
XMAX MOTOR, HIGH STRENGTH HOSE
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·April 24, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·April 13, 2011
FEMORAL HEAD COMPONENTS
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWY·July 23, 2008
BO-TOP 36500 QUADROX OXYGENATOR
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·November 14, 2017
CUSTOM TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
CUSTOM SURGERY PACK BO-TOP 36500/ QUADROX
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·September 28, 2017
BEQ-TOP 5210 ECC PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·November 9, 2017
CUSTOM PACK BO-T 25102
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017
CUSTOM TUBING PACK BO TOP 25102
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017