DYNASCOPE SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Dilator, Expansive Iris (Accessory)

FDA classification

FDA Class 2 ·Dilator, Expansive Iris (Accessory)

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

FDA classification

FDA Class 2 ·Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

ARGOS

FDA 510(k)

FDA Class 2 ·Neurology

SPIROLAB, SPIROLAB II

FDA 510(k)

FDA Class 2 ·Anesthesiology

G.o.c.c.l.e.s.

FDA 510(k)

FDA Class 2 ·Dental

Tricoglam Home Use

FDA 510(k)

FDA Class 2 ·Physical Medicine

NewTom 7G

FDA 510(k)

FDA Class 2 ·Radiology

JDentalCare Implant System JDIcon

FDA 510(k)

FDA Class 2 ·Dental

CustomizedBone Service

FDA 510(k)

FDA Class 2 ·Neurology

The Lipogems System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Doctor Tecar

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869

FDA 510(k)

FDA Class 2 ·General Hospital

Superbium

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NExT Station; NExT Station Advanced

FDA 510(k)

FDA Class 2 ·Neurology

B Dispensing Line

FDA 510(k)

FDA Class 2 ·General Hospital

EVA TPN BAG

FDA 510(k)

FDA Class 2 ·General Hospital

CalprestNG, EasyCal

FDA 510(k)

FDA Class 2 ·Immunology

COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic