Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval

FDA Class 3 ·ResQCPR System

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx

Ophthalmic Sealant

FDA Pre-Market Approval

FDA Class 3 ·RESURE SEALANT

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

Ophthalmic Sealant

FDA Pre-Market Approval

FDA Class 3 ·ReSure Sealant

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval

FDA Class 3 ·ResQCPR™ System

Ophthalmic Sealant

FDA Pre-Market Approval

FDA Class 3 ·ReSure Sealant

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx device

TOTAL BILIRUBIN REAGENT, CONCENTRATED

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LD1 ISOENZYME REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DELTON F PIT & FISSURE SEALANT

FDA 510(k)

FDA Class 2 ·Dental

TRUBYTE DENTURE BOND DENTURE BONDING AGENT

FDA 510(k)

FDA Class 2 ·Dental

SUREFLEX FILES

FDA 510(k)

FDA Class 1 ·Dental

CK-NAC 2-VIAL REAGENT W/SUBSTRATE START

FDA 510(k)

FDA Class 2 ·Clinical Chemistry