CARDIOCAP II TM CH-RESP MONITORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAREJECT DISPOSABLE SYRINGE AND NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

INION CPS BABY 1.5 BIOABSORBABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

OP300

FDA 510(k)

FDA Class 2 ·Radiology

AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DigiX FDX

FDA 510(k)

FDA Class 2 ·Radiology

Ez Catch Auto; Ez Catch YR; Ez Catch TR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

FDA 510(k)

FDA Class 2 ·Neurology

Destiknee Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059

FDA 510(k)

FDA Class 2 ·Dental

PLANMED SOPHIE

FDA 510(k)

FDA Class 2 ·Radiology

MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA

FDA 510(k)

FDA Class 2 ·Microbiology

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SEA-LINK Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2

FDA 510(k)

FDA Class 2 ·Ophthalmic

SATLITE TRANS PORTABLE PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

FDA 510(k)

FDA Class 2 ·Orthopedic