Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY.

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-ZYME ENZYMATIC CLEANER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON)

S57D DIGITAL OPERATING ROOM CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO 67D OPERATING ROOM CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-57 VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-52 ELECTRONIC VIDEO LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO LIGHT SOURCES AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-357 VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO 61D

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

T.B.R. ZIRCONNECT

FDA 510(k)

FDA Class 2 ·Dental

TBR IDEA CONIC/CONIC

FDA 510(k)

FDA Class 2 ·Dental

S-357 VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S51D DIGITAL ENDOSCOPY CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-41 &41S VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S52D DIGITAL VIDEO LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULMOCATH INTRABRONCHIAL CATHETER

FDA 510(k)

FDA Class 2 ·Radiology