60 results · 21ms · Sources: EU EUDAMED, 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