PLANMED VERITY

FDA 510(k)

FDA Class 2 ·Radiology

ORTHOCEPH OC100

FDA 510(k)

FDA Class 2 ·Dental

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A

FDA 510(k)

FDA Class 2 ·Immunology

cNeuro cMRI

FDA 510(k)

FDA Class 2 ·Radiology

CRANEX TOME CEPH, OR CRANEX TOME

FDA 510(k)

FDA Class 2 ·Dental

CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

SATLITE+/PB251+ PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Planmed Clarity 2D, Planmed Clarify S

FDA 510(k)

FDA Class 2 ·Radiology

VC150 VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Icare ic200

FDA 510(k)

FDA Class 2 ·Ophthalmic

DELTATRAC(TM) II METABOLIC MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M

FDA 510(k)

FDA Class 2 ·Immunology

MENISCUS ARROW, MODELS 531110, 531113, 531116

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

FDA 510(k)

FDA Class 2 ·Orthopedic

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PLANMED SOPHIE & PLANNED SOPHIE CLASSIC

FDA 510(k)

FDA Class 2 ·Radiology

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

B40i Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525

FDA 510(k)

FDA Class 2 ·Orthopedic

INION BIORESTORE

FDA 510(k)

FDA Class 2 ·Dental