Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES INSIGHT ULTRASONOMETER

Ovarian Adnexal Mass Assessment Score Test System

FDA classification

FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

Candida Species Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Candida Species Nucleic Acid Detection System

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

FDA classification

FDA Class 2 ·Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Needle, Phacoemulsification, Reprocessed

FDA classification

FDA Class 2 ·Needle, Phacoemulsification, Reprocessed

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

FDA classification

FDA Class 2 ·Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

FDA classification

FDA Class 2 ·Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Digital Pathology Display

FDA classification

FDA Class 2 ·Digital Pathology Display

Embryo Image Assessment System, Assisted Reproduction

FDA classification

FDA Class 2 ·Embryo Image Assessment System, Assisted Reproduction

Endoscopic Cytology Brush

FDA classification

FDA Class 2 ·Endoscopic Cytology Brush

Midazolam Syringe

FDA classification

FDA Class 2 ·Midazolam Syringe

Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

FDA classification

FDA Class 2 ·Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Oximeter, Wellness

FDA classification

FDA Class 2 ·Oximeter, Wellness

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·IPAFLUOROFOCON A AND B

Burn Resuscitation Decision Support Software

FDA classification

FDA Class 2 ·Burn Resuscitation Decision Support Software

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

FDA classification

FDA Class 2 ·Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Reprocessed Blood Pressure Cuff

FDA classification

FDA Class 2 ·Reprocessed Blood Pressure Cuff

Intraoral Cooling Device

FDA classification

FDA Class 2 ·Intraoral Cooling Device