20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GEM Flow COUPLER Device and System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
K162309
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code PGW·November 14, 2019
22G X 1.00IN (0.9 X 25 MM) INSYTE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·April 16, 2019
DIGITAL RADIOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
BIOSOMNIA-V3
FDA 510(k)
FDA Class 2
·Neurology
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 22, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·October 22, 2018
LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·June 12, 2017
LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·January 10, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 16, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014
SUPPORT ARM 176
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code IOY·May 21, 2013
6083 AMBULANCE COT
FDA Adverse Event
Injury
·STRYKER MEDICAL·Product code FPO·June 20, 2011
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DRE·December 7, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 15, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·April 13, 2017
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·December 11, 2019
LEAD EXTRACTION EVOLUTION SHORTIE MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·March 22, 2017
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·May 11, 2017
SEE H-10
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·June 30, 2015