Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES INSIGHT ULTRASONOMETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS

Quick-20m

FDA 510(k)

FDA Class 2 ·Neurology

AMEDITECH DRUGSMARTCUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COMPACS, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

AURADORM (NEUROMUSCULAR SLEEP)

FDA 510(k)

FDA Class 2 ·Dental

FLEXCATH STEERABLE SHEATH & DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEGVISION, MODEL EQ1000C SERIES

FDA 510(k)

FDA Class 2 ·Neurology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER

SABA Tampons

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Ige, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Antigen, Antiserum, Control

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·BAYER IMMUNO 1 SYSTEM

Ige, Peroxidase, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Peroxidase, Antigen, Antiserum, Control

Ige, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Rhodamine, Antigen, Antiserum, Control

Ige, Ferritin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Ferritin, Antigen, Antiserum, Control

Ige, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Fitc, Antigen, Antiserum, Control

Orthotoluidine, Glucose

FDA classification

FDA Class 2 ·Orthotoluidine, Glucose