Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CELUSOFT (POLYMACON) LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·(POLYMACON) SOF-FORM II CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOF-FORM ALLVUE MULTIFOCAL (POLYMACON) CONTACT LEN

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·(POLYMACON) CONTACT LENSES

MrOpen

FDA 510(k)

FDA Class 2 ·Radiology

Ruthless Spine RJB

FDA 510(k)

FDA Class 2 ·Orthopedic

PISTON SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.

FDA 510(k)

FDA Class 2 ·General Hospital

SurgiCube

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bpump Blood Pressure Cuff

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arm automatic blood pressure monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

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