Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphere

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-SPHERES MICROSPHERES

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphere

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE dilator kit: 9850DK EVOQUE loading system: 9850LS

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-SPHERES

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·Edwards EVOQUE Tricuspid Valve Replacement System

NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI

FDA 510(k)

FDA Class 3 ·Cardiovascular

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEW (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)

FDA 510(k)

FDA Class 3 ·Cardiovascular

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER

ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE

FDA 510(k)

FDA Class 3 ·Cardiovascular

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·MIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NTR/XTR Clip Delivery System; MitraClip G4 Clip Delivery System (NT, NTW, XT, XTW)