HEARTRAK SMART ECAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THERAKNIT GARMENT ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

Trojan Riviera Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QWIK-CALL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XPRESSE INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit

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