Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

THD BANDY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WINSIX Implant System

FDA 510(k)

FDA Class 2 ·Dental

YOUNG AGAIN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VESALIUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THD N-ANO ANOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cyber Blade

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LUBRIGYN CREAM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PTFE SURGICAL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THD REVOLUTION

FDA 510(k)

FDA Class 2 ·Radiology

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

FDA 510(k)

FDA Class 2 ·Dental

LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743

FDA 510(k)

FDA Class 2 ·Hematology

VRESELECT CULTURE MEDIUM

FDA 510(k)

FDA Class 2 ·Microbiology

Superbium

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202

FDA 510(k)

FDA Class 2 ·Immunology

DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY

FDA 510(k)

FDA Class 2 ·Hematology

HEMOGLOBIN ALC BY COLUMN TEST

FDA 510(k)

FDA Class 2 ·Hematology

LIQUICHEK RHEUMATOID FACTOR CONTROL

FDA 510(k)

FDA Class 2 ·Immunology