CBC-4K HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

Elecsys AMH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys Tg II

FDA 510(k)

FDA Class 2 ·Immunology

Thermi RF Accessories

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COAXIAL DILATOR SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm

FDA 510(k)

FDA Class 2 ·Neurology

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IRIDIUM SEEDS

FDA 510(k)

FDA Class 2 ·Radiology

TEARAWAY INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION

FDA 510(k)

FDA Class 2 ·Hematology

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS EDGE(TM) CORONARY DILITATION CATHETER

DR. JAHANGER'S CUTTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Neorad Pacs (Neorad Pacs)

FDA 510(k)

FDA Class 2 ·Radiology

NASALGUARD

FDA 510(k)

FDA Class 2 ·General Hospital

MIND MAP (20 CHANNEL EEG)

FDA 510(k)

FDA Class 2 ·Neurology

HYUNJAE DENTAL IMPRESSION MATERIALS

FDA 510(k)

FDA Class 2 ·Dental

DYNAMIC GAS SCAVENGING SYSTEM (DGSS)

FDA 510(k)

FDA Class 2 ·Anesthesiology