DELFIA DIGOXIN KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Planmeca ProMax 3D Max, Planmeca Maximity

FDA 510(k)

FDA Class 2 ·Radiology

cNeuro cDAT

FDA 510(k)

FDA Class 2 ·Radiology

PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT

FDA 510(k)

FDA Class 2 ·Dental

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INION CPS ORBITAL PLATES

FDA 510(k)

FDA Class 2 ·Dental

Planmeca Viso

FDA 510(k)

FDA Class 2 ·Radiology

NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

FDA 510(k)

FDA Class 2 ·Neurology

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

PANORAMIC X-RAY UNITS, MODIFICATION

FDA 510(k)

FDA Class 2 ·Dental

ULTRAMAX/MODEL NUMBER A1

FDA 510(k)

FDA Class 2 ·Radiology

GSP NEONATAL BIOTINIDASE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Neurology

PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)

FDA 510(k)

FDA Class 2 ·Radiology

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

RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

FDA 510(k)

FDA Class 2 ·Hematology