Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER, SAFIRE BI-DIRECTIONAL ABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM

LINK METAL-BACKED ACETABULAR CUPS

FDA 510(k)

FDA Class 3 ·Orthopedic

LIDGRER-LUND ACETABULAR SOCKETS

FDA 510(k)

FDA Class 3 ·Orthopedic

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION, INC. HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHAFILCON B) SOFT (HYDROPHILIC)...

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System with Integrated Embolic Protection

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF PLUS 60/W AND SPF-PLUS 60/M

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Kit, Test, In Vitro Periodontal

FDA Pre-Market Approval

FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

Kit, Test, In Vitro Periodontal

FDA Pre-Market Approval

FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP IMMUNOASSAY SYSTEM

THERAPEUTIC EXCHANGE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit