UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LEAD MODIFICATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

PULSTRON MODEL 100

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PULSE DEVICES

FDA 510(k)

FDA Class 3 ·Cardiovascular

DIRECTIONAL BOOT

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARCIAC PULSE GENERATOR 254-20

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 5984/5985

FDA 510(k)

FDA Class 3 ·Cardiovascular

#325 PROGRAMMABLE CARD. PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

EKG TRANSMITTER MODEL 5134

FDA 510(k)

FDA Class 3 ·Cardiovascular

VS-1 MODEL NUMBER 251K PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

COMMAND NP

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPTIMA MPT MODEL 5281E AND MODEL 5282E

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPTIMA MDT PULSE GENERATOR W/TELEMETRY

FDA 510(k)

FDA Class 3 ·Cardiovascular

EDP-20 PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK #326T PROGRAM/TELEMETRY BIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PROGRAMMABLE PULSE GENER

FDA 510(k)

FDA Class 3 ·Cardiovascular