60 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELEVATION
FDA 510(k)
FDA Class 1
·Physical Medicine
23ga Irrigator With Iris Manipulator
FDA UDI
KATALYST SURGICAL LLC·00840096205817·23ga Irrigator With Iris Manipulator
Exergen Temporal Scanner™
FDA UDI
EXERGEN CORPORATION·10834098002052·TAT2000 Temporal Scanner
23ga Irrigator, SP=No Iris Manipulator
FDA UDI
KATALYST SURGICAL LLC·00840096212761·23ga Irrigator, SP=No Iris Manipulator
TRULINK
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101007·NIBP,CUFF,1TB,ADULT,23-33CM,NYLON
CAPIOX FLEXIBLE VENOUS RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS KRAS MUTATION TEST
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 26, 2019
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas® KRAS Mutation Test
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas KRAS Mutation Test
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Roche cobas® KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas KRAS Mutation Test
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS KRAS MUTATION TEST
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas KRAS Mutation Test
FDA Pre-Market Approval
cobas® KRAS Mutation Test