PREXION3D ECLIPSE

FDA 510(k)

FDA Class 2 ·Radiology

IM-6 MICROINJECTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO KOWA NONMYD ALPHA-DIII

FDA 510(k)

FDA Class 2 ·Ophthalmic

K-Shield Advantage Port Access Infusion Set (PAIS)

FDA 510(k)

FDA Class 2 ·General Hospital

OMRON DIGITAL BP MONITOR HEM-700CP

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

FDA 510(k)

FDA Class 2 ·General Hospital

ANIMEC, MODELS AM-2S-4 AND AM-2S-5

FDA 510(k)

FDA Class 2 ·General Hospital

OMRON DIGITAL BP MONITOR HEM-400C

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMRON DIGITAL BP MONITOR HEM-700C

FDA 510(k)

FDA Class 2 ·Cardiovascular

Kawasumi Laboratories Blood Drawing Kit (BDK) System

FDA 510(k)

FDA Class 2 ·Hematology

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITAL SPHYGMOMANOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMRON ULTRASONIC NEBULIZER MODEL NE-UO5

FDA 510(k)

FDA Class 2 ·Anesthesiology

APEX OPTICAL IND. CO., EYE WEA MODELS

FDA 510(k)

FDA Class 1 ·Ophthalmic

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

ALLthread PEEK-OPTIMA

FDA UDI

Biomet Orthopedics, LLC·00880304644571·

ALLthread PEEK-OPTIMA

FDA UDI

Biomet Orthopedics, LLC·00880304644564·