PLASMAKINETIC ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RANDOX VALPROIC ACID

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TRANSFERRIN

FDA 510(k)

FDA Class 2 ·Immunology

CANNULATED LAG SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

FDA 510(k)

FDA Class 2 ·Dental

CLEARBLUE EASY EASY READ PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEUROSIGN MODEL 100

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EPSILON ULTRASONIC TIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYNERGY LT

FDA 510(k)

FDA Class 2 ·Neurology

CHROMOLITE EP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MASTALEX -MRSA, MODEL RST501

FDA 510(k)

FDA Class 2 ·Microbiology

Gelweave™ Vascular Prostheses

FDA 510(k)

FDA Class 2 ·Cardiovascular

VOXAR 3D PRODUCT FAMILY

FDA 510(k)

FDA Class 2 ·Radiology

MIRADA XD

FDA 510(k)

FDA Class 2 ·Radiology

O2 NASAL CANNULA WITH CO2 MONITORING

FDA 510(k)

FDA Class 2 ·Anesthesiology

iPulse SmoothSkin Gold Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTOSTAT II RHEUMATOID FACTOR IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

MICRODOT XTRA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry