123 results · 37ms · Sources: EU EUDAMED, US FDA

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Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

FDA Pre-Market Approval
cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas® EZH2 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Roche cobas® EZH2 Mutation Test

ReLine

FDA UDI
Nuvasive, Inc.·00195377046970·RELINE-O Trial, 10mm H Lamina W L-pop

Paradigm

FDA UDI
Proprio, Inc.·00850042604175·Paradigm DRF L-Rod, 100 mm

JEWELERS PRECISION FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059382·JEWELERS PRECISION FORCEPS #5A SERRATED HANDLE

OsteoMed

FDA UDI
OSTEOMED LLC·00845694010825·1.0mm Pilot Drill, Manual

Long Depth Gauge

FDA UDI
Osteocentric Technologies, Inc.·00810074306256·Long Depth Gauge

MicroAire®

FDA UDI
Microaire Surgical Instruments LLC·00847399000934·SMALL SAGITTAL SAW BLADE, 7.5mm X 15mm X 0.5mm

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 30, 2014