46 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIAPEEL PEELABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
CHASE CARDIOVASCULAR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
DINAMAP PRO 1000 MONITOR, MODEL 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
FASTI INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
UNKNOWN
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DTK·August 21, 2014
UNK
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·August 20, 2014
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·August 20, 2014
SYNERGY
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·January 6, 2012
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 4, 2015
2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 23, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·July 10, 2008
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·April 3, 2026
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·November 14, 2012
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 3, 2015
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 11, 2014
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·September 12, 2017
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 11, 2021
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·December 5, 2017
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 4, 2025