Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN FOR THE TLI SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A)

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·TLiIQ QCette

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

DUPUY S-ROM STD HIP STEM PROSTHESIS

FDA 510(k)

FDA Class 3 ·Orthopedic

SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

TELEMETRY WAND MODEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

VACUUM BAKE CYCLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

ULTRA SOFTWARE MODULE: MODEL 2016

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA 2, ASTRA 3, 4 & 6

FDA 510(k)

FDA Class 3 ·Cardiovascular

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·STAN S31 FETAL HEART MONITOR

HEART SYNC, MODELS C-100 AND T-100

FDA 510(k)

FDA Class 3 ·Cardiovascular

PELLETHANE 75D

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIX, MINIX ST, NEW IC: L74

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T4 AND T6

FDA 510(k)

FDA Class 3 ·Cardiovascular