FIX-L PEEK PLIF and T-PLIF System

FDA 510(k)

FDA Class 2 ·Orthopedic

VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MATRIXWAVE MMF SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

NATURALASE CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MIROCAM CAPSULE ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)

FDA 510(k)

FDA Class 2 ·Radiology

Europa (Alternative: AiRTouch) portable X-ray system

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON P200 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

TargetCool

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARTIMES BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Puritan Bennett 980 Ventilator System

FDA 510(k)

FDA Class 2 ·Anesthesiology

AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UNIMAX SUCTION IRRIGATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PAPAYA 3D & PAPAYA 3D Plus

FDA 510(k)

FDA Class 2 ·Radiology

ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VERTEX Reconstruction System

FDA 510(k)

FDA Class 2 ·Orthopedic

CryoVIVE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267

FDA 510(k)

FDA Class 2 ·Immunology

da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T

FDA 510(k)

FDA Class 2 ·Physical Medicine