21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Luminesse PMMA
FDA 510(k)
FDA Class 2
·Dental
LOGIQ P3
FDA 510(k)
FDA Class 2
·Radiology
EASYCARE ONLINE
FDA 510(k)
FDA Class 2
·Anesthesiology
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
FREESTYLE PRECISION NEO
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 10, 2017
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 5, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·May 17, 2013
PAIN CARE 3000
FDA Adverse Event
Injury
·BREG, INC·Product code MEB·June 20, 2011
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DRE·December 7, 2018
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
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
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
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