STERILIZATION WRAP-STERISHEET

FDA 510(k)

FDA Class 2 ·General Hospital

GENERAL SURGICAL LAPAROSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)

FDA 510(k)

FDA Class 2 ·Microbiology

Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GELBFISH FLEX VASCULAR DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR,INC. CORFLO(TM) MODEL 7.5S PTCA CATHETERS

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

TANDA MAX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AutoMIStar

FDA 510(k)

FDA Class 2 ·Radiology

TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA SKINCARE SYSTEM, MODEL: PTSCS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA RESTORE, MODEL PTSCS

FDA 510(k)

FDA Class 2 ·Physical Medicine

ZED Link

FDA 510(k)

FDA Class 2 ·Radiology