MAHE INSTRUMENTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TERRA FEMME

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT

FDA 510(k)

FDA Class 2 ·Radiology

Mag Vita TMS Therapy System w/Theta Burst Stimulation

FDA 510(k)

FDA Class 2 ·Neurology

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL

FDA 510(k)

FDA Class 2 ·Radiology

MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL

FDA 510(k)

FDA Class 2 ·Radiology

MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN

FDA 510(k)

FDA Class 2 ·Radiology

MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL

FDA 510(k)

FDA Class 2 ·Radiology

MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI

FDA 510(k)

FDA Class 2 ·Radiology

23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

MUTYH-Associated Polyposis (MAP)

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics