36 results
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29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HLM TUBING SET WITH BIOLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
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
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
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
CUSTOM TUBING PACK BEQ-TOP 25003 3/8X3/8 TO 7LPM
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·June 6, 2017
BEQ-TOP 22701 CUSTOM TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·October 3, 2017
LA CHILDREN'S ECC PACK - BEQ-TOP 49103
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·June 29, 2017
BEQ-TOP 40700 PEDIATRIC SPECIALTY PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·June 29, 2017
SMALL CARDIAC SURGERY PACK BO-T 46201
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 8, 2017
CUSTOM TUBING PACK BEQ-TOP 2202
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·August 7, 2018
BO-TOP 47600 LTX W/PEDI HSVR W/ORF32
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·August 1, 2017
ECC SMALL - RESPIRATORY BEQ-TOP 5210 CARDIOPULMONARY TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·January 9, 2018