eUnity

FDA 510(k)

FDA Class 2 ·Radiology

PERSONAL HEALTH CENTER (PHC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIPAP PRO 2 BI-LEVEL SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

ORTHODONTIC CERAMIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

Assure Titanium Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DEXIS CariVu 3-in-1 by KaVo

FDA 510(k)

FDA Class 2 ·Dental

MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WATCHMAN TruSeal Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOCARD® W onyx Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION ELEVEN Semi-Automated Urinalysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION MAX AX-4060 Urinalysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION EYE AI-4510 Urine Particle Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Multi-Lancet Device 2, ReliOn Premier Lancing Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EBI OMEGA21 SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SOLITAIRE-C CERVICAL SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI ESL SPINE SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI ACUMEN SURGICAL NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology