System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX-CEA (LIST 3A33)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-RIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-RIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

W & H LISA STEAM STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

EYESOPEN TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM

FDA 510(k)

FDA Class 2 ·Dental

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)

FDA 510(k)

FDA Class 2 ·Dental

CARTO® 3 EP Navigation System with Signal Processing Unit

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNILUX REVIVE AND BLUE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNILUX PLUS

FDA 510(k)

FDA Class 2 ·Physical Medicine

Radify Triage

FDA 510(k)

FDA Class 2 ·Radiology

OMNILUX REVIVE AND OMNILUX PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KALMATE MODEL 3A

FDA 510(k)

FDA Class 2 ·Neurology

MY ALLERGY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry