ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

FDA 510(k)

FDA Class 2 ·Hematology

ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS

FDA 510(k)

FDA Class 2 ·Hematology

MATRIX MICROSON 410

FDA 510(k)

FDA Class 2 ·Physical Medicine

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM TOTAL PSA

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

FDA 510(k)

FDA Class 2 ·Cardiovascular

WEBSTER DUO-DECAPOLAR CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAD/CAMouflage Milling Block

FDA 510(k)

FDA Class 2 ·Dental

HEMOCUE B-GLCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05

FDA 510(k)

FDA Class 2 ·Cardiovascular

WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,

FDA 510(k)

FDA Class 2 ·Cardiovascular

Delta 3300

FDA 510(k)

FDA Class 2 ·Cardiovascular

REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE

TRANSONIC FLOWMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE

FDA 510(k)

FDA Class 2 ·Neurology

CAS PSI SHOULDER

FDA 510(k)

FDA Class 2 ·Orthopedic

IASSIST KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE