CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Vatech Clismile

FDA 510(k)

FDA Class 2 ·Dental

T2 Plus

FDA 510(k)

FDA Class 2 ·Radiology

NT/IT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC

FDA 510(k)

FDA Class 2 ·Radiology

UNICONDYLAR FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

S9 GREENHILLS

FDA 510(k)

FDA Class 2 ·Anesthesiology

CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)

FDA 510(k)

FDA Class 2 ·Orthopedic

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

NYCOCARD CRP CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

MARIONETTE SA, MODEL 001 001 & 001 002

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

E-CUBE 7

FDA 510(k)

FDA Class 2 ·Radiology

CMS RECORD AND VERIFY

FDA 510(k)

FDA Class 2 ·Radiology

Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PAX-DUO3D PLUS, PCT-5000

FDA 510(k)

FDA Class 2 ·Radiology

SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RESCAN

FDA 510(k)

FDA Class 2 ·Anesthesiology

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)

FDA 510(k)

FDA Class 2 ·Radiology

iSchemaView RAPID

FDA 510(k)

FDA Class 2 ·Radiology