Pulse Generator, External Pacemaker, Dual Chamber

FDA Pre-Market Approval

FDA Class 2 ·RELIATY / MODEL 3145 PACING SYSTEM

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

E-EEGX, N-EEGX

FDA 510(k)

FDA Class 2 ·Neurology

CARESCAPE B450

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRANEX BASEX D OR CRANEX EXCEL D

FDA 510(k)

FDA Class 2 ·Dental

CREATININE (ENZYMATIC)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UREA/BUN, SCAL, NORTROL, ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NAVIGATOR APPLICATIONS SUITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

CARESCAPE B450, E-musb

FDA 510(k)

FDA Class 2 ·Cardiovascular

MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMIX PANORAD AND SOMARAD

FDA 510(k)

FDA Class 2 ·Radiology

CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Entropy Module, E-ENTROPY-01

FDA 510(k)

FDA Class 2 ·Neurology

SCANORA 3D

FDA 510(k)

FDA Class 2 ·Dental

CRANEX NOVUS

FDA 510(k)

FDA Class 2 ·Dental

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

FDA 510(k)

FDA Class 2 ·Anesthesiology

PANORAD, PANORAD SL

FDA 510(k)

FDA Class 2 ·Radiology

TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARESCAPE B650, E-musb

FDA 510(k)

FDA Class 2 ·Cardiovascular