CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SNAPSHOT

FDA 510(k)

FDA Class 2 ·Dental

Bindex BI-100

FDA 510(k)

FDA Class 2 ·Radiology

BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS

FDA 510(k)

FDA Class 2 ·Dental

OP300

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CARDIOCAP DR-124 RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mediracer NCS

FDA 510(k)

FDA Class 2 ·Neurology

PM 2002 CC PROLINE

FDA 510(k)

FDA Class 2 ·Dental

DELFIA NEONATAL THYROXINE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR

FDA 510(k)

FDA Class 1 ·Cardiovascular

RUBALEX, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

SALIVA-STIM

FDA 510(k)

FDA Class 1 ·Dental

Icare HOME tonometer

FDA 510(k)

FDA Class 2 ·Ophthalmic

PLANMECA PROONE

FDA 510(k)

FDA Class 2 ·Dental

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)

FDA 510(k)

FDA Class 2 ·Orthopedic

ADMARK

FDA 510(k)

FDA Class 1 ·Radiology

PROSTYLE INTRA

FDA 510(k)

FDA Class 2 ·Dental

SATLITE/PB251 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular