ASAHI Silverway

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visera Hysterovideoscope Olympus HYF Type V

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Microperimeter MP-3, Microperimeter MP-3 Type S

FDA 510(k)

FDA Class 2 ·Ophthalmic

Specular Microscope CEM- 530

FDA 510(k)

FDA Class 2 ·Ophthalmic

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASSALLO GT 018 G12; VASSALLO GT 018 G30

FDA 510(k)

FDA Class 2 ·Cardiovascular

5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

AUTION EYE AI-4510 Urine Particle Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

NON-CONTACT TONOMETER, MODEL FT-1000

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICROPERIMETER MP-3

FDA 510(k)

FDA Class 2 ·Ophthalmic

PREXION3D ECLIPSE

FDA 510(k)

FDA Class 2 ·Radiology

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

FDA 510(k)

FDA Class 2 ·General Hospital

Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B

FDA 510(k)

FDA Class 2 ·Orthopedic

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bio-Medicus Adult Cannulae and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

FDA 510(k)

FDA Class 2 ·Dental

BIO-INTRAFIX TIBIAL SCREW AND SHEATH

FDA 510(k)

FDA Class 2 ·Orthopedic

VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Blue Sky Bio Zygomatic Implant System

FDA 510(k)

FDA Class 2 ·Dental