THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

FDA 510(k)

FDA Class 2 ·Radiology

Visualase V2 MRI-guided Laser Ablation System (9736422)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Visualase MRI-Guided Laser Ablation System (SW 3.4)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monteris Medical NeuroBlate System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRANBERG Thermoguide Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

WELLCOGEN BACTERIAL ANTIGEN KIT

FDA 510(k)

FDA Class 2 ·Microbiology

FREEDOM CONSTRAINED LINERS

FDA 510(k)

FDA Class 2 ·Orthopedic

WILLCOGEN MENINGITIDIS KIT ZL25

FDA 510(k)

FDA Class 2 ·Microbiology

SCHWABE RADIUS PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

35/CD CINECONVERTER

FDA 510(k)

FDA Class 2 ·Radiology

RADIUS OSTEOTOMY PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51

FDA 510(k)

FDA Class 2 ·Microbiology

WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

FDA 510(k)

FDA Class 2 ·Microbiology

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ANI BIOCARD HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry